Idiopathic Parkinson's DiseasePhase 1NCT05094011
Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease
A Phase 1 study testing Aadipose-Derived Mesenchymal Stem Cells in people with Idiopathic Parkinson's Disease, run by Taiwan Mitochondrion Applied Technology Co., Ltd..
Trial summary
Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD) Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Aadipose-Derived Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Jul 2028
- Phase
- Phase 1
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Aged 45 to 70 years old (inclusive) at Screening
- Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"
- With at least 5 years since the diagnosis of Parkinson's disease
- With responsiveness to levodopa or dopa agonist. This is defined as improvement between ''Off'' and ''On'' MDS-UPDRS by at least 33% of the Motor MDS-UPDRS
- Idiopathic Parkinson's disease of Stage 3 ~ 4 of modified Hoehn \& Yahr staging during ''ON'' time
Show all 10Show fewer
- Stable Parkinsonian medications for at least 2 months prior to the Screening Visit
- MRI not showing gross atrophy or any brain pathology other than PD
- Mini-Mental State Examination (MMSE) ≧ 24
- With score of the Beck Depression Inventory (BDI-II) < 29 and Hamilton Rating Scale for Depression (HAM-D-17) < 25
Who cannot join
- Atypical or secondary Parkinsonism
- With neurodegenerative disorders other than PD
- Unable to receive MRI or PET scanning
- With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery
- Received any other investigational agent within 4 weeks prior to Screening
- History of intracranial surgeries or implantation of a device for Parkinson's disease 2 years prior to Screening
Show all 40Show fewer
- Major surgery within the previous 6 months at Screening
- Significant cardiovascular disease, including:
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Uncontrolled hypertension: Blood pressure >140/90 mmHg
- History of serious ventricular arrhythmia
- Malignancy within 2 years prior to Screening
- Any diagnosis of autoimmune disease or immune compromised state and requiring systemic steroid or immunosuppressive treatment
- Any other severe systemic disorder, including history of schizophrenia or other psychotic disorders, stroke, seizure, traumatic brain injury, or central nervous system infection, which judged by the investigator that entering the trial may be detrimental to the subject
- Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments
- Positive in any of the following regulatory authority-licensed screening tests:
- HIV antigen/antibody combo test
- Anti-HCV test
- Hepatitis B surface antigen (HBsAg) test
- Rapid plasma reagin (RPR) test
- HIV-1 nucleic acid test (NAT)
- HBV NAT
- HCV NAT
- Any of the following hematologic abnormalities:
- Hemoglobin < 9.0 g/dL,
- ANC < 1,500/μL
- Platelets < 100,000/μL
- Any of the following serum biochemistry abnormalities:
- Total bilirubin > 1.5 × ULN
- AST or ALT > 2.5 × ULN
- r-GT > 2.5 × ULN
- ALP > 2.5 × ULN
- serum albumin < 3.0 g/dL
- creatinine > 1.5 × ULN
- Female subject who is lactating or has positive serum or urine pregnancy test at Screening Visit
- Female subject with childbearing potential or male subject with female spouse/partner with childbearing potential who refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening until Final/Early Termination Visit. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
- With any condition judged by the investigator that entering the trial may be detrimental to the subject
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease
Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)
Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation
Read the detailed description
MitoCell is an autologous stem cell product that cultures with the company's unique patented medium. The mechanism of action of MitoCell is to improve the brain microenvironment in neurodegenerative disease. MitoCell which like mesenchymal stem cells modulate the immune response, and secrete more BDNF and SDF-1 neurotrophic factors than regular stem cell products.Therefore, MitoCell can protect and repair damaged dopamine neurons (DA) and stimulate DA regeneration.This project is a phase I open-label dose-escalation study to evaluate the safety, tolerability, and efficacy of autologous MitoCell intracranial transplantation in subjects with idiopathic Parkinson's disease which rating from stage 3 ~ 4 of modified Hoehn \& Yahr staging.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Aadipose-Derived Mesenchymal Stem Cells
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aadipose-Derived Mesenchymal Stem CellsBiological
Also called MitoCell
Stereotactic intrastriatal implantation of 3×10^7 per hemisphere (total 6×10^7 cells) or 1×10^8 per hemisphere (total 2×10^8 cells) autologous TM01-treated adipose-derived mesenchymal stem cells (MitoCell).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Autologous MitoCell Transplantation in Subjects with Idiopathic Parkinson's Disease Receives: Biological: Aadipose-Derived Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading of Adverse Events
Grading will be assessed using NCI CTCAE, version 5.0.
Measured: within 48 weeks after MitoCell transplantation
Routine physical examinations
Safety of Mitocell will be assessed by routine physical examinations. Physical examination conducted in this study will include general appearance, skin, eyes, ears, nose,throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal,neurological, etc.
Measured: within 48 weeks after MitoCell transplantation
Changes in physical examinations: clinical standard neurological examination [Safety of Mitocell]
Clinical standard neurological examination by study investigator. Changes in motor function, sensory function, cranial nerve function (visual fields), cortical functions and reflexes are followed in the examination, scored as normal - abnormal without clinical relevance - abnormal with clinical relevance
Measured: within 48 weeks after MitoCell transplantation
Changes in vital signs: blood pressure [Safety of Mitocell]
Changes in blood pressure during the study , measured as systolic and diastolic blood pressure (in mmHg)
Measured: within 48 weeks after MitoCell transplantation
Changes in vital signs: pulse rate [Safety of Mitocell]
Changes in pulse rate during the study (in beats per minute)
Measured: within 48 weeks after MitoCell transplantation
Changes in vital signs: body temperature [Safety of Mitocell]
Changes in body temperature during the study (in degrees celsius)
Measured: within 48 weeks after MitoCell transplantation
Changes in clinical laboratory safety screen: haematology - hemoglobin [Safety of Mitocell]
Changes in laboratory variables for haematology: hemoglobin (g/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Measured: within 48 weeks after MitoCell transplantation
Changes in clinical laboratory safety screen: Platelet count [Safety of Mitocell]
Changes in laboratory variables for haematology: Platelet count (10E9/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Measured: within 48 weeks after MitoCell transplantation
Changes in clinical laboratory safety screen: white blood cell (WBC) counts [Safety of Mitocell]
Changes in laboratory variables for haematology: Cell counts (10E9/L) for total WBC, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Measured: within 48 weeks after MitoCell transplantation
Changes in clinical laboratory safety screen: International Normalized Ratio (INR) [Safety of Mitocell]
Changes in laboratory variables for haematology: INR (standardized prothrombin time) to determine the effects of oral anticoagulants on the clotting system. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Measured: within 48 weeks after MitoCell transplantation
Changes in clinical laboratory safety screen: activated partial thromboplastin time (aPTT) [Safety of Mitocell]
Changes in laboratory variables for haematology: aPTT (sec) . Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Measured: within 48 weeks after MitoCell transplantation
Electrocardiogram (ECG)
Safety of Mitocell will be assessed by any clinically significant abnormalities on ECG results as compared to Baseline. A standard 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Measured: within 48 weeks after MitoCell transplantation
Magnetic Resonance Imaging (MRI)
Safety of Mitocell will be assessed by any clinically significant abnormalities on MRI scans as compared to Baseline.
Measured: within 48 weeks after MitoCell transplantation
Secondary outcomes (8)
MDS-UPDRS (Movement Disorder Society unified Parkinson's disease rating scale)
Change in MDS-UPDRS motor (Part III) "OFF" score compared to the baseline. All items have 5 response options with uniform anchors of: 0 = normal, 1 = slight (symptoms/signs with sufficiently low frequency or intensity to cause no impact on function), 2 = mild (symptoms/signs of frequency or intensity sufficient to cause a modest impact on function, 3 = moderate (symptoms/signs sufficiently frequent or intense to impact considerably, but not prevent function), 4 = severe (symptoms/signs that prevent function).
Measured: at 12, 24, 48 weeks
Modified Hoehn & Yahr staging
Change in Modified Hoehn \& Yahr staging compared to the baseline.
Measured: at 12, 24, 48 weeks
18F-DOPA PET
Degree of radiotracer uptake increment/decrement shown on striatum of 18F-DOPA PET compared to the baseline.
Measured: at 48 weeks
levodopa equivalent daily dose (LEDD)
Reduction of Parkinson's medications consumption by calculating levodopa equivalent daily dose (LEDD) compared to the baseline.
Measured: at 12, 24, 48 weeks
PDQ-39 (Parkinson's Disease Questionnaire)
Change in PDQ-39 scale compared to the baseline. The PDQ-39 is a 39 questions Parkinson's Disease self-completed questionnaire that comprises 8 domains: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). All items are assumed to impact QoL and must be answered to compute scores for each dimension. Questions are answered based on experiences from the preceding month using a 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each scores range from 0 = never have difficulty to 100 = always have difficulty.
Measured: at 12, 24, 48 weeks
Beck Depression Inventory (BDI-II) scores
Net change from baseline in BDI-II scores. BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
Measured: at 48 weeks
Hamilton Depression Rating Scale (HAM-D-17) scores
Net change from baseline in HAM-D-17 scores. The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed).
Measured: at 48 weeks
Mini Mental State Examination (MMSE) Scores
Net change from baseline in MMSE scores. The MMSE uses a 30 point questionnaire to measure cognitive impairment. The MMSE is scored from 0 to 30,with a score equal to or greater than 24 points indicating normal cognition, a score of 19-23 points indicating mild cognitive impairment, 10-18 points indicating moderate impairment and a score equal to or below 9 indicating severe impairment.
Measured: at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study plans to enroll approximately 4 subjects to obtain 3 evaluable subjects successfully receiving 3×10\^7 cells/hemisphere (total 6×10\^7 cells, Cohort 1) and approximately 8 subjects to obtain 6 evaluable subjects for 1×10\^8 cells/hemisphere (total 2×10\^8 cells, Cohort 2)
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiwan Mitochondrion Applied Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chi-Tang Tu, Ph. D., Study director, Taiwan Mitochondrion Applied Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094011
- Sponsor's protocol ID
- MITOCELL-01
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05094011
- Acronym / sponsor ID
- MITOCELL-01
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Taiwan Mitochondrion Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 26 Oct 2021 (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.
Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)
Secondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation
Detailed description
MitoCell is an autologous stem cell product that cultures with the company's unique patented medium. The mechanism of action of MitoCell is to improve the brain microenvironment in neurodegenerative disease. MitoCell which like mesenchymal stem cells modulate the immune response, and secrete more BDNF and SDF-1 neurotrophic factors than regular stem cell products.Therefore, MitoCell can protect and repair damaged dopamine neurons (DA) and stimulate DA regeneration.This project is a phase I open-label dose-escalation study to evaluate the safety, tolerability, and efficacy of autologous MitoCell intracranial transplantation in subjects with idiopathic Parkinson's disease which rating from stage 3 ~ 4 of modified Hoehn \& Yahr staging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study plans to enroll approximately 4 subjects to obtain 3 evaluable subjects successfully receiving 3×10^7 cells/hemisphere (total 6×10^7 cells, Cohort 1) and approximately 8 subjects to obtain 6 evaluable subjects for 1×10^8 cells/hemisphere (total 2×10^8 cells, Cohort 2)
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Biological: Aadipose-Derived Mesenchymal Stem CellsAutologous MitoCell Transplantation in Subjects with Idiopathic Parkinson's Disease |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form
- Aged 45 to 70 years old (inclusive) at Screening
- Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the "Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease"
- With at least 5 years since the diagnosis of Parkinson's disease
- With responsiveness to levodopa or dopa agonist. This is defined as improvement between ''Off'' and ''On'' MDS-UPDRS by at least 33% of the Motor MDS-UPDRS
Key exclusion criteria (40 listed)
- Atypical or secondary Parkinsonism
- With neurodegenerative disorders other than PD
- Unable to receive MRI or PET scanning
- With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery
- Received any other investigational agent within 4 weeks prior to 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 |
|---|---|---|
| Aadipose-Derived Mesenchymal Stem CellsAlso: MitoCellStereotactic intrastriatal implantation of 3×10^7 per hemisphere (total 6×10^7 cells) or 1×10^8 per hemisphere (total 2×10^8 cells) autologous TM01-treated adipose-derived mesenchymal stem cells (MitoCell). | Biological | Single Arm Study |
Primary outcome
Grading of Adverse Events
Time frame: within 48 weeks after MitoCell transplantation
Grading will be assessed using NCI CTCAE, version 5.0.
Routine physical examinations
Time frame: within 48 weeks after MitoCell transplantation
Safety of Mitocell will be assessed by routine physical examinations. Physical examination conducted in this study will include general appearance, skin, eyes, ears, nose,throat, head and neck, heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal,neurological, etc.
Changes in physical examinations: clinical standard neurological examination [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Clinical standard neurological examination by study investigator. Changes in motor function, sensory function, cranial nerve function (visual fields), cortical functions and reflexes are followed in the examination, scored as normal - abnormal without clinical relevance - abnormal with clinical relevance
Changes in vital signs: blood pressure [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in blood pressure during the study , measured as systolic and diastolic blood pressure (in mmHg)
Changes in vital signs: pulse rate [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in pulse rate during the study (in beats per minute)
Changes in vital signs: body temperature [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in body temperature during the study (in degrees celsius)
Changes in clinical laboratory safety screen: haematology - hemoglobin [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in laboratory variables for haematology: hemoglobin (g/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Changes in clinical laboratory safety screen: Platelet count [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in laboratory variables for haematology: Platelet count (10E9/L). Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Changes in clinical laboratory safety screen: white blood cell (WBC) counts [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in laboratory variables for haematology: Cell counts (10E9/L) for total WBC, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Changes in clinical laboratory safety screen: International Normalized Ratio (INR) [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in laboratory variables for haematology: INR (standardized prothrombin time) to determine the effects of oral anticoagulants on the clotting system. Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Changes in clinical laboratory safety screen: activated partial thromboplastin time (aPTT) [Safety of Mitocell]
Time frame: within 48 weeks after MitoCell transplantation
Changes in laboratory variables for haematology: aPTT (sec) . Result evaluated as "normal", "abnormal without clinical relevance" or "abnormal with clinical relevance"
Electrocardiogram (ECG)
Time frame: within 48 weeks after MitoCell transplantation
Safety of Mitocell will be assessed by any clinically significant abnormalities on ECG results as compared to Baseline. A standard 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Magnetic Resonance Imaging (MRI)
Time frame: within 48 weeks after MitoCell transplantation
Safety of Mitocell will be assessed by any clinically significant abnormalities on MRI scans as compared to Baseline.
8 secondary outcomes
MDS-UPDRS (Movement Disorder Society unified Parkinson's disease rating scale)
Time frame: at 12, 24, 48 weeks
Modified Hoehn & Yahr staging
Time frame: at 12, 24, 48 weeks
18F-DOPA PET
Time frame: at 48 weeks
levodopa equivalent daily dose (LEDD)
Time frame: at 12, 24, 48 weeks
PDQ-39 (Parkinson's Disease Questionnaire)
Time frame: at 12, 24, 48 weeks
Beck Depression Inventory (BDI-II) scores
Time frame: at 48 weeks
Hamilton Depression Rating Scale (HAM-D-17) scores
Time frame: at 48 weeks
Mini Mental State Examination (MMSE) Scores
Time frame: at 48 weeks
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 21 Nov 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Chi-Tang Tu, Ph. D. study director
Taiwan Mitochondrion Applied Technology Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aadipose-Derived Mesenchymal Stem Cells in people with Idiopathic Parkinson's Disease, run by Taiwan Mitochondrion Applied Technology Co., Ltd..
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 10 inclusion and 40 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: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Contact Kuo-Wei Hsueh, Ph. D. (886-03-5820208, fskenneth@taimito.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of Adverse Events (time frame: within 48 weeks after MitoCell transplantation). The study lists 13 primary outcomes in all. 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 21 Nov 2024.