PARKINSON DISEASE (Disorder)Phase 1/2SPARC-PDNCT07751640
Autologous Bone Marrow Aspirate (IV) and Bone Marrow Concentrate (Intranasal) for Parkinson's Disease and Parkinson-Plus Syndromes (SPARC-PD)
A Phase 1/2 study testing Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC) in people with PARKINSON DISEASE (Disorder) and Atypical Parkinsonism, run by Apeiron Research Center at 1 site in United States.
Trial summary
This pilot study evaluated the safety, tolerability, and exploratory epigenetic outcomes of a single same-day autologous bone marrow procedure in adults with Parkinson's disease (PD) or Parkinson-plus syndromes (PPS). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Atypical Parkinsonism
- What is being tested?
- Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 4 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General:
- Participants diagnosed with PD or PPS by a licensed medical professional
- Documented diagnosis of PD or PPS ≤ 6 years
- Participants with an anticipated survival of at least 3 years in the investigator's opinion
- Participants who are willing and able to give informed consent
- Participants who can comply with the study protocol over the 6-month duration
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- Stable medical profile for 60 days prior to the initial intake screening
- Participants can ambulate at least 25m without assistance
- No known history of heparin-induced thrombocytopenia
- Willingness to comply with study requirements and provide informed consent
- Participants have no history of adverse reactions to heparin, e.g., HIT, local numbing medications, adhesives, or skin sterilizing agents
- PD Inclusion Criteria:
- Idiopathic Parkinson's disease patients who meet the MDS's Clinical Diagnostic Criteria for Parkinson's disease
- Responsive to levodopa or dopamine agonists defined by 33% improvement in "Off"/"On" symptoms by MDS-UPDRS-III
- A modified Hoehn and Yahr stage of 3 or less
- Neuroimaging findings are consistent with PD and absent of atrophy or other brain pathology inconsistent with PD
- "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
- PPS Inclusion Criteria:
- (DLB)
- High probability of cognitive capacity to give informed consent by the Montreal - Cognitive Assessment (MoCA), with a value 23
- Probable DLB - DLB consortium: Two or more core clinical features are present (including features of parkinsonism for the study), or only one core clinical feature is present, but with one or more indicative biomarkers
- Core clinical features:
- Fluctuating cognition with pronounced variations in attention and alertness
- Recurrent visual hallucinations that are typically well-formed and detailed
- Rapid eye movement (REM) sleep behavior disorder (RBD), which may precede cognitive decline
- One or more spontaneous cardinal features of parkinsonism: bradykinesia, resting tremor, or rigidity
- Indicative biomarkers:
- Reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT/PET
- Abnormal (low uptake) I-MIBG myocardial scintigraphy
- Polysomnographic confirmation of REM sleep without atonia
- (PSP)
- MDS Diagnostic Criteria for probable PSP with predominant parkinsonism (PSP-P)
- Ocular motor dysfunction: vertical supranuclear gaze palsy or slow velocity of vertical saccades or frequent macro square wave jerks ("eyelid-opening apraxia")
- Ocular motor dysfunction + akinetic-rigid, axial predominant, levodopa resistant or with tremor and/or asymmetric and/or levodopa responsive (akinesia)
- "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
- (MSA)
- MDS Diagnostic Criteria for clinically probable MSA
- Autonomic dysfunction
- Parkinsonism
- Cerebellar syndrome, including at least one of gait ataxia, limb ataxia, cerebellar dysarthria, or oculomotor features
- "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
- (CBD)
- Chronic progressive course
- Asymmetric onset
- Higher cortical dysfunction: apraxia, speech apraxia, non-fluent aphasia, alien limb phenomena, or cortical sensory loss
- Movement disorder: rigid/akinetic syndrome and either dystonic limb posturing or focal myoclonus in limb, and levodopa-resistant
- "Normal" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value 26
Who cannot join
- Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
- No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
- Unable to maintain/tolerate supine position with cervical neck extension
- Active systemic infection or local infection near the lumbar pelvis region
- Any bone marrow aspiration from the pelvis within 6 months of initial screening
- Any musculoskeletal-pelvis contraindications to BMA harvest from the PSIS
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- Concurrent enrollment in another PD/PPS study or having taken/received another investigational intervention within 6 weeks of initial screening
- Malignancy diagnosed 2 years prior to initial screening
- History of intracranial or nasopharyngeal surgery deemed detrimental to the participant during the trial, including brain surgery/stereotactic procedure for PD/PPS
- History of electroconvulsive therapy
- Chronic Kidney Disorder (CKD) > Stage II or eGFR <60 mL/min
- Autoimmune disease, including:
- Rheumatoid Arthritis (RA)
- Systemic Lupus Erythematosus (SLE)
- Any disorders of glucocorticoid excess or diseases requiring systemic steroids or immune-modulating therapies
- Cardiac disease deemed significant:
- Poorly controlled hypertension (BP 140/90)
- NYHA class III or IV congestive heart failure
- History of a significant ventricular arrhythmia
- Obesity class II or higher (BMI 35)
- Moderate-to-uncontrolled diabetes HbA1c 7%
- Osteoporosis
- A history of other severe systemic disorders, including significant CVA, TBI, seizure, encephalitis, meningitis, or psychiatric disorder that is deemed potentially harmful to the participant by the PI
- Positive for HIV, HBV, HCV, or syphilis
- Any of the following lab abnormalities:
- Hematology: Hgb < 10 g/dl, ANC < 1.550/L, platelets < 100,000 /L
- Chemistry: albumin < 3.0 g/dL, serum creatine > 1.5 x ULN, total bilirubin > 1.5 x ULN, AST/ALT/ALP > 2.0 x ULN
- Female or another gender with childbearing potential not willing to adopt barrier method(s) of contraception, plus one other form, including:
- Intrauterine system (IUS)
- Intrauterine device (IUD)
- Oral, injected, or implanted hormonal contraception
- Female or another gender who is lactating/breastfeeding or has a positive urine or serum pregnancy test at intake screening
- Any disorder that compromises the participant's ability to give appropriate informed consent or hinders the ability to perform the assessment and receive the study's interventions
- Any other condition not listed above that is deemed potentially harmful to the participant by the PI
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Biologics Research Center
Boulder, Colorado, 80303
About this study
Official title: A Single-Arm, Open-Label, Within-Subject Pilot Study (Phase I/IIa) Evaluating the Safety, Tolerability, and Exploratory Epigenetic Outcomes of a Single Same-Day Administration of Autologous Bone Marrow Aspirate (Intravenous) and Autologous Bone Marrow Aspirate Concentrate (Intranasal) in Adults With Parkinson's Disease or Parkinson-Plus Syndromes
This pilot study evaluated the safety, tolerability, and exploratory epigenetic outcomes of a single same-day autologous bone marrow procedure in adults with Parkinson's disease (PD) or Parkinson-plus syndromes (PPS). Ten participants underwent posterior superior iliac spine bone marrow aspiration under local anesthesia. The unprocessed aspirate (BMA) was filtered and administered intravenously via normal saline infusion on the same day. A portion of the aspirate was centrifuged to produce a bone marrow aspirate concentrate (BMAC), which was atomized intranasally using a mucosal atomization device. Cells were not expanded in culture or genetically modified. The procedure was performed under the Same Surgical Procedure exception (21 CFR 1271.15(b)); an investigational new drug application (IND 31770) was submitted to the FDA Center for Biologics Evaluation and Research (CBER).
The primary outcome was safety and tolerability, assessed by treatment-emergent adverse events (TEAEs) graded per CTCAE v5.0 criteria through 12 months post-treatment. Exploratory outcomes included DNA methylation biological age (GrimAge-based composite and organ/system Systems Age clocks) measured from peripheral blood at baseline and approximately 6 months, and characterization of the delivered cell product by automated hematology and multiparameter flow cytometry.
Read the detailed description
Parkinson's disease (PD) and Parkinson-plus syndromes (PPS), including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal syndrome (CBS), and Lewy body dementia (LBD), are progressive neurodegenerative disorders characterized by motor dysfunction, non-motor symptoms, and progressive disability. Currently available therapies are primarily symptomatic and do not alter the underlying neurodegenerative process.
Autologous bone marrow aspirate contains mesenchymal stromal cells (MSCs), hematopoietic progenitor cells, and numerous trophic, immunomodulatory, and anti-inflammatory bioactive factors that may support neuronal repair and tissue homeostasis. Preclinical studies suggest these cells and associated soluble factors may promote neuroprotection by modulating inflammation, oxidative stress, mitochondrial dysfunction, and neurotrophic signaling. Because the cell product is autologous and minimally manipulated, it avoids ex vivo culture expansion and genetic modification and is expected to have low immunogenic potential.
Intranasal administration may facilitate transport of cells and soluble factors to the central nervous system through olfactory and trigeminal pathways, while intravenous administration provides systemic exposure. Combining both delivery routes may provide complementary central nervous system and peripheral biologic effects using a single same-day autologous procedure.
This pilot study was designed primarily to evaluate the safety and tolerability of combined intravenous bone marrow aspirate (BMA) and intranasal bone marrow aspirate concentrate (BMAC) administration in adults with PD or PPS. Exploratory objectives include evaluation of changes in DNA methylation-derived biological age biomarkers and characterization of the administered autologous cell product.
- Being tested
- Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)
- Keywords
- Parkinson Disease, Parkinson_Plus Syndrome, Stem Cells, MSCs, Epigenetics, Metagenomics
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)Biological
Same-day autologous bone marrow aspirate (BMA) administered intravenously and bone marrow aspirate concentrate (BMAC) administered intranasally via mucosal atomization. Both products derived from a single posterior superior iliac spine aspiration. No ex vivo expansion, genetic modification, or cryopreservation performed.
| Study group | Role | What they receive |
|---|---|---|
| Autologous BMA (IV) and BMAC (Intranasal) | Experimental | Participants received a single same-day autologous bone marrow procedure consisting of: (1) intravenous infusion of filtered, unprocessed bone marrow aspirate (BMA) in normal saline; and (2) intranasal atomization of bone marrow aspirate concentrate (BMAC). Both products were derived from a single posterior superior iliac spine (PSIS) aspiration performed under local anesthesia on the same day. Cells were not expanded in culture or genetically modified. Receives: Biological: Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence, severity, and relationship to study treatment of treatment-emergent adverse events (TEAEs) following a single same-day autologous bone marrow procedure consisting of intravenous bone marrow aspirate (BMA) and intranasal bone marrow aspirate concentrate (BMAC). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to adverse event). Serious adverse events (SAEs) include death, life-threatening events, hospitalization or prolongation of hospitalization, persistent or significant disability, congenital anomaly, or other important medical events. TEAEs will be recorded throughout the study and assessed by the investigator for relationship to study treatment.
Measured: Baseline through Month 12
Secondary outcomes (40)
Mean Change from Baseline in GrimAge Biological Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation GrimAge assay. GrimAge biological age will be estimated in years at baseline and Month 6. The outcome will be reported as the mean participant-level change from baseline to Month 6. Negative values indicate a reduction in estimated biological age.
Measured: Baseline and 6 months
Bone Marrow Mesenchymal Stromal Cell (MSC) Concentration
Bone marrow mesenchymal stromal cell (MSC) concentration in the administered bone marrow aspirate (intravenous) and bone marrow aspirate concentrate (intranasal), quantified by multiparameter flow cytometry using a Sysmex XF-1600 analyzer. MSCs are identified by sequential gating of singlets, viable cells (7-AAD negative), CD45-negative cells, and CD271-positive/CD73-positive cells. Outcome reported as MSC concentration (cells/mL).
Measured: Day 0
Change in Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score
Change from baseline to Months 3, 6, and 12 in the Movement Disorder Society Non-Motor Rating Scale (MDS-NMS). The MDS-NMS assesses the frequency and severity of non-motor symptoms in Parkinson's disease. Higher total scores indicate greater non-motor symptom burden and worse disease severity.
Measured: Baseline, Month 3, Month 6, and Month 12
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Change from baseline to Months 3, 6, and 12 in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index, a measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating poorer health-related quality of life.
Measured: Baseline, Month 3, Month 6, and Month 12
Change in Non-Motor Symptoms Questionnaire (NMSQ) Score
Change from baseline to Months 3, 6, and 12 in the Non-Motor Symptoms Questionnaire (NMSQ). Scores range from 0 to 30, with higher scores indicating more non-motor symptoms.
Measured: Baseline, Month 3, Month 6, and Month 12
Change in SCOPA-Autonomic (SCOPA-AUT) Score
Change from baseline to Months 3, 6, and 12 in the SCales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT). Total scores range from 0 to 69. Higher scores indicate greater autonomic symptom burden and worse autonomic dysfunction.
Measured: Baseline, Month 3, Month 6, and Month 12
Change in SCOPA-Cognition (SCOPA-COG) Score
Change from baseline to Months 3, 6, and 12 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG). Total scores range from 0 to 43, with higher scores indicating better cognitive function.
Measured: Baseline, Month 3, and Month 6
Change in Five Times Sit-to-Stand Test (FTSTS)
Change from baseline to Month 6 in time required to complete the Five Times Sit-to-Stand Test. Outcome reported in seconds. Lower values indicate better lower extremity functional performance.
Measured: Baseline and Month 6
Change in 10-Meter Walk Test (10MWT)
Change from baseline to Month 6 in gait speed measured using the 10-Meter Walk Test. Outcome reported as walking speed (meters/second). Higher values indicate better walking performance.
Measured: Baseline and Month 6
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Change from baseline to Month 6 in the Unified Multiple System Atrophy Rating Scale (UMSARS). Higher scores indicate greater disease severity.
Measured: Baseline and Month 6
Change in Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Change from baseline to Month 6 in the Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS). Scores range from 0 to 21. Higher scores indicate greater disease severity.
Measured: Baseline and Month 6
Change in Hoehn and Yahr Stage
Change from baseline to Month 6 in Hoehn and Yahr stage. Stages range from 1 to 5. Higher stages indicate greater disease severity.
Measured: Baseline and Month 6
Change in Short Parkinson's Evaluation Scale/Scales for Outcomes in Parkinson's Disease-Motor (SPES/SCOPA-Motor) Score
Change from baseline to Month 6 in the SPES/SCOPA-Motor score. Scores range from 0 to 42. Higher scores indicate worse motor impairment.
Measured: Baseline and Month 6
Change in Montreal Cognitive Assessment (MoCA) Score
Change from baseline to Months 3, 6, and 12 in the Montreal Cognitive Assessment (MoCA), a validated screening instrument for global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline, Month 3, and Month 6
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) Motor Examination Score
Change from baseline to Month 6 in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) Motor Examination score. Scores range from 0 to 132. Higher scores indicate greater motor impairment.
Measured: Baseline and Month 6
Change in Gut Microbiota Composition
Exploratory descriptive analysis of gut microbiota composition using shotgun metagenomic sequencing of stool specimens. Analyses include microbial taxonomic composition, alpha diversity, beta diversity, relative microbial abundance, and microbial community structure
Measured: Baseline and Month 6
Change in Nasopharyngeal Microbiota Composition
Exploratory descriptive analysis of nasopharyngeal microbiota composition using shotgun metagenomic sequencing. Analyses include microbial taxonomic composition, alpha diversity, beta diversity, relative microbial abundance, and microbial community structure.
Measured: Baseline and 6 months
Change in White Blood Cell Count
Change in total white blood cell count measured by automated hematology analyzer. Results summarized descriptively using observed values and change from baseline.
Measured: Day 0 and 6 months
TNAP-Positive Mesenchymal Stromal Cell Concentration
Concentration of tissue non-specific alkaline phosphatase (TNAP/MSCA-1)-positive mesenchymal stromal cells within the CD271-positive/CD73-positive MSC population, quantified by multiparameter flow cytometry. Outcome reported as TNAP-positive MSC concentration (cells/mL).
Measured: Day 0
Mesenchymal Stromal Cell Frequency
Frequency of mesenchymal stromal cells among viable nucleated bone marrow cells, quantified by multiparameter flow cytometry. Outcome reported as the percentage of viable nucleated cells identified as CD271-positive/CD73-positive MSCs.
Measured: Day 0
Total Mesenchymal Stromal Cell Dose
Total number of mesenchymal stromal cells delivered to each participant through intravenous bone marrow aspirate and intranasal bone marrow aspirate concentrate administration. Absolute cell counts are calculated using volumetric counting beads.
Measured: Day 0
Mesenchymal Stromal Cell Viability
Percentage of viable mesenchymal stromal cells in the administered cell product as determined by 7-aminoactinomycin D (7-AAD) exclusion using multiparameter flow cytometry.
Measured: Day 0
Change in White Blood Cell Count
Change in total white blood cell count measured by automated hematology analyzer. White blood cell count will be summarized descriptively as observed values and change from baseline to evaluate hematologic safety following intranasal autologous bone marrow aspirate concentrate administration.
Measured: Baseline to Month 6
Change in Hemoglobin Concentration
Change in hemoglobin concentration measured by automated hematology analyzer. Results will be summarized descriptively to evaluate hematologic safety.
Measured: Baseline to Month 6
Change in Platelet Count
Change in platelet count measured by automated hematology analyzer. Results will be summarized descriptively.
Measured: Baseline to Month 6
Change in Serum Creatinine
Change in serum creatinine concentration measured by standard clinical chemistry methods. Results will be summarized descriptively to evaluate renal safety.
Measured: Baseline to Month 6
Change in Alanine Aminotransferase (ALT)
Change in serum alanine aminotransferase concentration measured by standard clinical chemistry methods. Results will be summarized descriptively to evaluate hepatic safety.
Measured: Baseline to Month 6
Change in Aspartate Aminotransferase (AST)
Change in serum aspartate aminotransferase concentration measured by standard clinical chemistry methods. Results will be summarized descriptively.
Measured: Baseline to Month 6
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Change in serum high-sensitivity C-reactive protein concentration measured using a high-sensitivity immunoassay. Results will be summarized descriptively to evaluate changes in systemic inflammation following treatment.
Measured: Baseline to Month 6
Change in Erythrocyte Sedimentation Rate (ESR)
Change in erythrocyte sedimentation rate measured using the Westergren method. Results will be summarized descriptively to evaluate systemic inflammatory activity following treatment.
Measured: Baseline to Month 6
Mean Change from Baseline in Cellular Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Cellular Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Brain Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Brain Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Kidney Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Kidney Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Muscle Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Muscle Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Immune Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Immune Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Lung Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Lung Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Vascular Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Vascular Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Extracellular Matrix (ECM) Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Extracellular Matrix Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Metabolic Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Metabolic Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Mean Change from Baseline in Inflammation Systems Age
Whole-blood DNA methylation will be analyzed using the Clock Foundation Systems Age algorithm. Inflammation Systems Age will be estimated in years at baseline and Month 6 and summarized as the mean participant-level change from baseline.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 May 2025
- Primary completion4 Sep 2026 (estimated)
- Study completion4 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject pre/post design. Each participant serves as their own control, with baseline (Day 0) measurements compared to 6-month and 12-month follow-up assessments. No placebo or sham arm was included in this pilot phase. The single-arm design was selected because the primary objective is safety and feasibility characterization, for which an internal control is appropriate and a concurrent control group is not required.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apeiron Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason W Glowney, MD, MSc, Principal investigator, Apeiron Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751640
- Sponsor's protocol ID
- BBRC-PDPILOT-01
- Acronym
- SPARC-PD
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the primary publication will be made available upon reasonable request to qualified researchers. Data shared will include: epigenetic clock measurements (baseline and 6-month), peripheral hematologic and biochemical laboratory values (baseline and 6-month), cell product characterization data (TNC, viability, MSC counts), and adverse event records. Data will be de-identified in accordance with HIPAA Safe Harbor standards. Requests should be directed to the corresponding author and will be reviewed by the principal investigator. A data use agreement (DUA) will be required prior to data transfer. Data will be available beginning 12 months after publication of the primary results manuscript and will remain available for 5 years.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Within-Subject Pilot Study (Phase I/IIa) Evaluating the Safety, Tolerability, and Exploratory Epigenetic Outcomes of a Single Same-Day Administration of Autologous Bone Marrow Aspirate (Intravenous) and Autologous Bone Marrow Aspirate Concentrate (Intranasal) in Adults With Parkinson's Disease or Parkinson-Plus Syndromes
- ClinicalTrials.gov ID
- NCT07751640
- Acronym / sponsor ID
- SPARC-PD / BBRC-PDPILOT-01
- Keywords
- Parkinson Disease, Parkinson_Plus Syndrome, Stem Cells, MSCs, Epigenetics, Metagenomics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Apeiron Research CenterUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 4 Sep 2026 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study evaluated the safety, tolerability, and exploratory epigenetic outcomes of a single same-day autologous bone marrow procedure in adults with Parkinson's disease (PD) or Parkinson-plus syndromes (PPS). Ten participants underwent posterior superior iliac spine bone marrow aspiration under local anesthesia. The unprocessed aspirate (BMA) was filtered and administered intravenously via normal saline infusion on the same day. A portion of the aspirate was centrifuged to produce a bone marrow aspirate concentrate (BMAC), which was atomized intranasally using a mucosal atomization device. Cells were not expanded in culture or genetically modified. The procedure was performed under the Same Surgical Procedure exception (21 CFR 1271.15(b)); an investigational new drug application (IND 31770) was submitted to the FDA Center for Biologics Evaluation and Research (CBER).
The primary outcome was safety and tolerability, assessed by treatment-emergent adverse events (TEAEs) graded per CTCAE v5.0 criteria through 12 months post-treatment. Exploratory outcomes included DNA methylation biological age (GrimAge-based composite and organ/system Systems Age clocks) measured from peripheral blood at baseline and approximately 6 months, and characterization of the delivered cell product by automated hematology and multiparameter flow cytometry.
Detailed description
Parkinson's disease (PD) and Parkinson-plus syndromes (PPS), including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal syndrome (CBS), and Lewy body dementia (LBD), are progressive neurodegenerative disorders characterized by motor dysfunction, non-motor symptoms, and progressive disability. Currently available therapies are primarily symptomatic and do not alter the underlying neurodegenerative process.
Autologous bone marrow aspirate contains mesenchymal stromal cells (MSCs), hematopoietic progenitor cells, and numerous trophic, immunomodulatory, and anti-inflammatory bioactive factors that may support neuronal repair and tissue homeostasis. Preclinical studies suggest these cells and associated soluble factors may promote neuroprotection by modulating inflammation, oxidative stress, mitochondrial dysfunction, and neurotrophic signaling. Because the cell product is autologous and minimally manipulated, it avoids ex vivo culture expansion and genetic modification and is expected to have low immunogenic potential.
Intranasal administration may facilitate transport of cells and soluble factors to the central nervous system through olfactory and trigeminal pathways, while intravenous administration provides systemic exposure. Combining both delivery routes may provide complementary central nervous system and peripheral biologic effects using a single same-day autologous procedure.
This pilot study was designed primarily to evaluate the safety and tolerability of combined intravenous bone marrow aspirate (BMA) and intranasal bone marrow aspirate concentrate (BMAC) administration in adults with PD or PPS. Exploratory objectives include evaluation of changes in DNA methylation-derived biological age biomarkers and characterization of the administered autologous cell product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject pre/post design. Each participant serves as their own control, with baseline (Day 0) measurements compared to 6-month and 12-month follow-up assessments. No placebo or sham arm was included in this pilot phase. The single-arm design was selected because the primary objective is safety and feasibility characterization, for which an internal control is appropriate and a concurrent control group is not required.
| Arm | Type | Receives |
|---|---|---|
| Autologous BMA (IV) and BMAC (Intranasal) | Experimental | Biological: Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)Participants received a single same-day autologous bone marrow procedure consisting of: (1) intravenous infusion of filtered, unprocessed bone marrow aspirate (BMA) in normal saline; and (2) intranasal atomization of bone marrow aspirate concentrate (BMAC). Both products were derived from a single posterior superior iliac spine (PSIS) aspiration performed under local anesthesia on the same day. Cells were not expanded in culture or genetically modified. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- Participants diagnosed with PD or PPS by a licensed medical professional
- Documented diagnosis of PD or PPS ≤ 6 years
- Participants with an anticipated survival of at least 3 years in the investigator's opinion
- Participants who are willing and able to give informed consent
- Participants who can comply with the study protocol over the 6-month duration
Key exclusion criteria (34 listed)
- Other non-PD/PPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)
- No strong familial history of PD/PPS not attributable to environmental exposure or any known genetic predisposition to PD/PPS
- Unable to maintain/tolerate supine position with cervical neck extension
- Active systemic infection or local infection near the lumbar pelvis region
- Any bone marrow aspiration from the pelvis within 6 months of initial screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC)Same-day autologous bone marrow aspirate (BMA) administered intravenously and bone marrow aspirate concentrate (BMAC) administered intranasally via mucosal atomization. Both products derived from a single posterior superior iliac spine aspiration. No ex vivo expansion, genetic modification, or cryopreservation performed. | Biological | Autologous BMA (IV) and BMAC (Intranasal) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Month 12
Incidence, severity, and relationship to study treatment of treatment-emergent adverse events (TEAEs) following a single same-day autologous bone marrow procedure consisting of intravenous bone marrow aspirate (BMA) and intranasal bone marrow aspirate concentrate (BMAC). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to adverse event). Serious adverse events (SAEs) include death, life-threatening events, hospitalization or prolongation of hospitalization, persistent or significant disability, congenital anomaly, or other important medical events. TEAEs will be recorded throughout the study and assessed by the investigator for relationship to study treatment.
40 secondary outcomes
Mean Change from Baseline in GrimAge Biological Age
Time frame: Baseline and 6 months
Bone Marrow Mesenchymal Stromal Cell (MSC) Concentration
Time frame: Day 0
Change in Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Time frame: Baseline, Month 3, Month 6, and Month 12
Change in Non-Motor Symptoms Questionnaire (NMSQ) Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change in SCOPA-Autonomic (SCOPA-AUT) Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change in SCOPA-Cognition (SCOPA-COG) Score
Time frame: Baseline, Month 3, and Month 6
Change in Five Times Sit-to-Stand Test (FTSTS)
Time frame: Baseline and Month 6
Change in 10-Meter Walk Test (10MWT)
Time frame: Baseline and Month 6
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: Baseline and Month 6
Change in Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Time frame: Baseline and Month 6
Change in Hoehn and Yahr Stage
Time frame: Baseline and Month 6
Change in Short Parkinson's Evaluation Scale/Scales for Outcomes in Parkinson's Disease-Motor (SPES/SCOPA-Motor) Score
Time frame: Baseline and Month 6
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, Month 3, and Month 6
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) Motor Examination Score
Time frame: Baseline and Month 6
Change in Gut Microbiota Composition
Time frame: Baseline and Month 6
Change in Nasopharyngeal Microbiota Composition
Time frame: Baseline and 6 months
Change in White Blood Cell Count
Time frame: Day 0 and 6 months
TNAP-Positive Mesenchymal Stromal Cell Concentration
Time frame: Day 0
Mesenchymal Stromal Cell Frequency
Time frame: Day 0
Total Mesenchymal Stromal Cell Dose
Time frame: Day 0
Mesenchymal Stromal Cell Viability
Time frame: Day 0
Change in White Blood Cell Count
Time frame: Baseline to Month 6
Change in Hemoglobin Concentration
Time frame: Baseline to Month 6
Change in Platelet Count
Time frame: Baseline to Month 6
Change in Serum Creatinine
Time frame: Baseline to Month 6
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline to Month 6
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline to Month 6
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline to Month 6
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline to Month 6
Mean Change from Baseline in Cellular Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Brain Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Kidney Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Muscle Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Immune Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Lung Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Vascular Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Extracellular Matrix (ECM) Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Metabolic Systems Age
Time frame: Baseline and Month 6
Mean Change from Baseline in Inflammation Systems Age
Time frame: Baseline and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the primary publication will be made available upon reasonable request to qualified researchers. Data shared will include: epigenetic clock measurements (baseline and 6-month), peripheral hematologic and biochemical laboratory values (baseline and 6-month), cell product characterization data (TNC, viability, MSC counts), and adverse event records. Data will be de-identified in accordance with HIPAA Safe Harbor standards. Requests should be directed to the corresponding author and will be reviewed by the principal investigator. A data use agreement (DUA) will be required prior to data transfer. Data will be available beginning 12 months after publication of the primary results manuscript and will remain available for 5 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason W Glowney, MD, MSc principal investigator
Apeiron Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Bone Marrow Aspirate (BMA) and Bone Marrow Aspirate Concentrate (BMAC) in people with PARKINSON DISEASE (Disorder) and Atypical Parkinsonism, run by Apeiron Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.