Idiopathic Parkinson DiseasePhase 1/2SVFP1NCT05699161
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
A Phase 1/2 study testing Adipose-derived stromal vascular fraction cells in people with Idiopathic Parkinson Disease and Parkinson's Disease and Parkinsonism, run by Samuel Vilchez, PhD at 1 site in Nicaragua.
Trial summary
This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Parkinson Disease, Parkinson's Disease and Parkinsonism
- What is being tested?
- Adipose-derived stromal vascular fraction cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNicaragua
- Study dates
- 14 Oct 2021to 31 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one year
- Age 18 - 80; male or female
- Stable PD medication for at least 30 days prior to study enrollment
- A MDS-UPDRS total score > 20 and < 50
- Ability to understand the study and sign consent forms
- Intent to comply with all postoperative appointments
- Social support to be able to comply with all follow-up visits
Who cannot join
- Previous neurological disease or previous brain trauma as a confounding factor
- Cardiovascular disease or any condition that prohibits general anesthesia
- Inability to understand and / or cooperate with investigators
- Subjects that have a history of injury, infection, or deformity of at or near the anatomical site for planned product injection which may increase their risk for infection, injury, or complication related to the product (e.g., prior injury to blood vessels, lymphatics, history of orbital injury/fracture).
- Rash or possible skin infection over surgical sites or face.
- Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the past year.
- Current substance abuse (drugs or alcohol) within the 6 months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Hospital Escuela Oscar Danilo Rosales Arguello
León, León Department
About this study
Official title: Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study
This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face.
This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.
Read the detailed description
Pre-procedure/intervention evaluation
Patients had a medical history, physical exam, and medication review. Neurological examination used two instruments: PDQ-39 and the MDS-UPDRS, the latter including videorecording of a standardized motor examination. Subjects also completed the general health questionnaire SF-36 and have blood drawn for subsequent biomarker analysis (immune markers L-1beta, IL-2, IL-6, IL-10, and TNF-alpha). Patients had pre-operative laboratory studies (hemogram, coagulation profile, electrolytes, BUN, creatinine, and urinalysis) and anesthesia evaluation carried out 48 hours prior to procedures.
Surgical and biochemical technique
The autologous fat tissue was harvested via liposuction by a plastic surgeon. The fat was washed and processed with collagenase for 60 minutes at a temperature of 39-41ºC, in an incubator and by constant shaking with a rotary shaker. The digested adipose tissue was then centrifuged for 14 minutes in 3 steps and the cell fraction (SVF) contained in the fat was removed with a syringe. The cell count was performed using a Luna Stem cell counter (Logos Bio). SVF was injected the same day as the liposuction and adipose processing.
A standardized total dose of 30x10e6 SVF cells was administered [Carstens 2017]. Injections of SVF cells bilateral (into the subdermal plane along the submuscular aponeurotic fascia) 1 cc per site for a final dose of 0.3 million cells per site
Post-surgical and management of complications
Patients were observed for potentially adverse effects for 24 hours after the procedure. There were follow-up visits at seven days, 1-, 3-, 6- and 12 months postoperative and treatment period.
- Being tested
- Adipose-derived stromal vascular fraction cells
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stromal vascular fraction cellsGenetic
Published minimal clinically important differences (MCID) for PDQ-39; MDS-UPDRS; and levo-dopa equivalent dose and changes in the levels of blood proteins (L-1beta, IL-2, IL-6, IL-10, and TNF-alpha) in 10 patients after 12 months of treatment with SVF cells.
| Study group | Role | What they receive |
|---|---|---|
| Single group assignment. | Experimental | Bilateral treatment.
Subdermal plane injection of SVF cells into the submuscular aponeurotic fascia of the face. Receives: Genetic: Adipose-derived stromal vascular fraction cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events
Documentation of adverse events
Measured: 12-months follow-up post intervention.
L-dopa medication
Changes in L-dopa medication measured as levodopa-equivalent dose.
Measured: Up to month 12 post intervention.
Minimal clinically important differences (MCIDs)-1
Estimation of MCIDs scores (0-199) based on the UPDRS scale: : MCID 4.3 points low, MCID 8.1 points medium, and MCID 17.1 points high.
Measured: Up to 12-months post SVF treatment
Minimal clinically important differences (MCIDs)-2
Estimation of MCIDs scores (0-100) based on the PDQ-39 scale: : MCID 4.7 minimal, MCID 7.7 moderate, and MCID 10.1 significant.
Measured: Up to 12-months post SVF treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start14 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Vilchez, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, Ministerio de Salud, Nicaragua, GID BIO, Inc., National Autonomous University of Nicaragua
- Responsible party
- Sponsor-investigator, Samuel Vilchez, PhD, National Autonomous University of Nicaragua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699161
- Sponsor's protocol ID
- Nica-Parkinson-2021
- Acronym
- SVFP1
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carstens M, Haq I, Martinez-Cerrato J, Dos-Anjos S, Bertram K, Correa D. Sustained clinical improvement of Parkinson's disease in two patients with facially-transplanted adipose-derived stromal vascular fraction cells. J Clin Neurosci. 2020 Nov;81:47-51. doi: 10.1016/j.jocn.2020.09.001. Epub 2020 Sep 25.
PubMed 33222965Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.
PubMed 28177263Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
PubMed 26565755Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
PubMed 26546112Lindvall O. Treatment of Parkinson's disease using cell transplantation. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19;370(1680):20140370. doi: 10.1098/rstb.2014.0370.
PubMed 26416681Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
PubMed 20065131Horvath K, Aschermann Z, Kovacs M, Makkos A, Harmat M, Janszky J, Komoly S, Karadi K, Kovacs N. Changes in Quality of Life in Parkinson's Disease: How Large Must They Be to Be Relevant? Neuroepidemiology. 2017;48(1-2):1-8. doi: 10.1159/000455863. Epub 2017 Feb 4.
PubMed 28161701
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Parkinson Disease With Transplantation of SVF Cells of Adipose Origin: Safety and Exploratory Efficacy Study
- ClinicalTrials.gov ID
- NCT05699161
- Acronym / sponsor ID
- SVFP1 / Nica-Parkinson-2021
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samuel Vilchez, PhDUniversity, hospital or other
- Collaborators
- Wake Forest University, Ministerio de Salud, Nicaragua, GID BIO, Inc., National Autonomous University of Nicaragua
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 26 Jan 2023 (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 is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face.
This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.
Detailed description
Pre-procedure/intervention evaluation
Patients had a medical history, physical exam, and medication review. Neurological examination used two instruments: PDQ-39 and the MDS-UPDRS, the latter including videorecording of a standardized motor examination. Subjects also completed the general health questionnaire SF-36 and have blood drawn for subsequent biomarker analysis (immune markers L-1beta, IL-2, IL-6, IL-10, and TNF-alpha). Patients had pre-operative laboratory studies (hemogram, coagulation profile, electrolytes, BUN, creatinine, and urinalysis) and anesthesia evaluation carried out 48 hours prior to procedures.
Surgical and biochemical technique
The autologous fat tissue was harvested via liposuction by a plastic surgeon. The fat was washed and processed with collagenase for 60 minutes at a temperature of 39-41ºC, in an incubator and by constant shaking with a rotary shaker. The digested adipose tissue was then centrifuged for 14 minutes in 3 steps and the cell fraction (SVF) contained in the fat was removed with a syringe. The cell count was performed using a Luna Stem cell counter (Logos Bio). SVF was injected the same day as the liposuction and adipose processing.
A standardized total dose of 30x10e6 SVF cells was administered [Carstens 2017]. Injections of SVF cells bilateral (into the subdermal plane along the submuscular aponeurotic fascia) 1 cc per site for a final dose of 0.3 million cells per site
Post-surgical and management of complications
Patients were observed for potentially adverse effects for 24 hours after the procedure. There were follow-up visits at seven days, 1-, 3-, 6- and 12 months postoperative and treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group assignment. | Experimental | Genetic: Adipose-derived stromal vascular fraction cellsBilateral treatment. Subdermal plane injection of SVF cells into the submuscular aponeurotic fascia of the face. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with UK brain bank criteria for idiopathic Parkinson's disease for a period of not less than one year
- Age 18 - 80; male or female
- Stable PD medication for at least 30 days prior to study enrollment
- A MDS-UPDRS total score > 20 and < 50
- Ability to understand the study and sign consent forms
Key exclusion criteria (7 listed)
- Previous neurological disease or previous brain trauma as a confounding factor
- Cardiovascular disease or any condition that prohibits general anesthesia
- Inability to understand and / or cooperate with investigators
- Subjects that have a history of injury, infection, or deformity of at or near the anatomical site for planned product injection which may increase their risk for infection, injury, or complication related to the product (e.g., prior injury to blood vessels, lymphatics, history of orbital injury/fracture).
- Rash or possible skin infection over surgical sites or face.
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 |
|---|---|---|
| Adipose-derived stromal vascular fraction cellsPublished minimal clinically important differences (MCID) for PDQ-39; MDS-UPDRS; and levo-dopa equivalent dose and changes in the levels of blood proteins (L-1beta, IL-2, IL-6, IL-10, and TNF-alpha) in 10 patients after 12 months of treatment with SVF cells. | Genetic | Single group assignment. |
Primary outcome
Incidence of treatment related adverse events
Time frame: 12-months follow-up post intervention.
Documentation of adverse events
L-dopa medication
Time frame: Up to month 12 post intervention.
Changes in L-dopa medication measured as levodopa-equivalent dose.
Minimal clinically important differences (MCIDs)-1
Time frame: Up to 12-months post SVF treatment
Estimation of MCIDs scores (0-199) based on the UPDRS scale: : MCID 4.3 points low, MCID 8.1 points medium, and MCID 17.1 points high.
Minimal clinically important differences (MCIDs)-2
Time frame: Up to 12-months post SVF treatment
Estimation of MCIDs scores (0-100) based on the PDQ-39 scale: : MCID 4.7 minimal, MCID 7.7 moderate, and MCID 10.1 significant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 33222965Carstens M, Haq I, Martinez-Cerrato J, Dos-Anjos S, Bertram K, Correa D. Sustained clinical improvement of Parkinson's disease in two patients with facially-transplanted adipose-derived stromal vascular fraction cells. J Clin Neurosci. 2020 Nov;81:47-51. doi: 10.1016/j.jocn.2020.09.001. Epub 2020 Sep 25.
- Background: PubMed 28177263Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.
- Background: PubMed 26565755Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
- Background: PubMed 26546112Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
- Background: PubMed 26416681Lindvall O. Treatment of Parkinson's disease using cell transplantation. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19;370(1680):20140370. doi: 10.1098/rstb.2014.0370.
- Background: PubMed 20065131Shulman LM, Gruber-Baldini AL, Anderson KE, Fishman PS, Reich SG, Weiner WJ. The clinically important difference on the unified Parkinson's disease rating scale. Arch Neurol. 2010 Jan;67(1):64-70. doi: 10.1001/archneurol.2009.295.
- Background: PubMed 28161701Horvath K, Aschermann Z, Kovacs M, Makkos A, Harmat M, Janszky J, Komoly S, Karadi K, Kovacs N. Changes in Quality of Life in Parkinson's Disease: How Large Must They Be to Be Relevant? Neuroepidemiology. 2017;48(1-2):1-8. doi: 10.1159/000455863. Epub 2017 Feb 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adipose-derived stromal vascular fraction cells in people with Idiopathic Parkinson Disease and Parkinson's Disease and Parkinsonism, run by Samuel Vilchez, PhD at 1 site in Nicaragua.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 Nicaragua. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 related adverse events (time frame: 12-months follow-up post intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05699161, which also lists 7 linked publications.
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 26 Jan 2023.