Parkinson's DiseaseNCT00976430
Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease
A study testing Autologous Bone marrow derived stem cells transplant in people with Parkinson's Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
Trial summary
This study is intended to look at the safety and efficacy of the use of autologous bone marrow derived stem cell transplant in patients with advanced Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Autologous Bone marrow derived stem cells transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2009to 30 Apr 2012
- Phase
- Interventional
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 35-70 years of age.
- Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
- Patients with at least 5 years since the disease.
- Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
- PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.
- Stable Parkinsonian medications for the 60 days prior to the surgical therapy.
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- MRI not showing gross atrophy or any other pathology of brain.
- Patients with score less than 19 for the Montgomery-Asberg Rating Scale (MADRS) for Depression.
- NO Significant cognitive impairment.MMSE > 24.
- The participant is able to comply with and understand the required visit schedule and all required tests and procedures.
- The participant (and/or LAR) must sign an informed consent.
Who cannot join
- History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- History of psychiatric disorders like schizophrenia or psychotic disorders.
- History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- Contraindication for MRI
- General medical contraindications for surgery like coagulopathy
- Subjects with abnormal hematology and chemistry values, unless the out of range values are clinically significant with respect to general surgery.
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- Severe skin infection or osteomyelitis at the site of bone marrow aspiration potentially limiting the procedure.
- Positive test results for HIV.
- History of drug or alcohol abuse
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease
This study is intended to look at the safety and efficacy of the use of autologous bone marrow derived stem cell transplant in patients with advanced Parkinson's disease.
Read the detailed description
Parkinson's disease, a neurodegenerative disorder, still at its best can only be controlled by medical or surgical treatment. For more than two decades various groups have tried using modified cell transplants for curing this disease. Earlier results with use of fetal mesencephalic cell transplant were encouraging, but this had to be discontinued due to severe side effects.
Current interest, in the use of Mesenchymal stem cells as a pluripotent cell for developing neural cells has been the background for this study. Reliance Life sciences had found encouraging results with the use of human MSCs in Rat model of PD. Based on this and other data, Jaslok Hospital and Research Centre has initiated a pilot study to investigate the efficacy of Autologous MSCs in treating advanced PD. This cells will be harvested from bone marrow, processed at RLS laboratory and transplanted by stereotactic techniques into the striatum of the patient.
- Conditions
- Parkinson's Disease
- Being tested
- Autologous Bone marrow derived stem cells transplant
- Keywords
- Autologous 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.
Autologous Bone marrow derived stem cells transplantProcedure or surgery
Also called stem cells, cell therapy for Parkinson's disease
Stem cells are derived from the bone marrow of the patient and processed at Reliance life sciences.The stem cells are the stereotactically implanted in the striatum.
| Study group | Role | What they receive |
|---|---|---|
| Therapy for Parkinson's disease | Experimental | Stem cell derived from the bone marrow of the patient will be stereotactically transplanted in the striatum.These stem cell are the expected to grow up into dopamine secreting neural cells. Receives: Procedure: Autologous Bone marrow derived stem cells transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.
Measured: Up to 18 months from the day of stem cell transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJul 2009
- Primary completion30 Nov 2011
- Study completion30 Apr 2012
Why it stopped: Adequate no. of patients could not be recruited in the set time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaslok Hospital and Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Paresh Doshi, Jaslok Hospital and Research Centre
- Investigators
- Paresh k Doshi, MCh, Principal investigator, Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976430
- Sponsor's protocol ID
- JHC525
- Status last verified
- Aug 2018
- First submitted
- 11 Sep 2009
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arias-Carrion O, Yuan TF. Autologous neural stem cell transplantation: a new treatment option for Parkinson's disease? Med Hypotheses. 2009 Nov;73(5):757-9. doi: 10.1016/j.mehy.2009.04.029. Epub 2009 May 24.
PubMed 19467573
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00976430
- Acronym / sponsor ID
- JHC525
- Conditions
- Parkinson's Disease
- Keywords
- Autologous Stem Cells.
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate no. of patients could not be recruited in the set time frame.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jaslok Hospital and Research CentreUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- 30 Nov 2011 (actual)
- Study completion
- 30 Apr 2012 (actual)
- First posted
- 14 Sep 2009 (estimated)
- 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 study is intended to look at the safety and efficacy of the use of autologous bone marrow derived stem cell transplant in patients with advanced Parkinson's disease.
Detailed description
Parkinson's disease, a neurodegenerative disorder, still at its best can only be controlled by medical or surgical treatment. For more than two decades various groups have tried using modified cell transplants for curing this disease. Earlier results with use of fetal mesencephalic cell transplant were encouraging, but this had to be discontinued due to severe side effects.
Current interest, in the use of Mesenchymal stem cells as a pluripotent cell for developing neural cells has been the background for this study. Reliance Life sciences had found encouraging results with the use of human MSCs in Rat model of PD. Based on this and other data, Jaslok Hospital and Research Centre has initiated a pilot study to investigate the efficacy of Autologous MSCs in treating advanced PD. This cells will be harvested from bone marrow, processed at RLS laboratory and transplanted by stereotactic techniques into the striatum of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy for Parkinson's disease | Experimental | Procedure: Autologous Bone marrow derived stem cells transplantStem cell derived from the bone marrow of the patient will be stereotactically transplanted in the striatum.These stem cell are the expected to grow up into dopamine secreting neural cells. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female between 35-70 years of age.
- Patient with current diagnosis of PD with motor complications (as confirmed by neurologist) as per the standard criteria and guidelines.
- Patients with at least 5 years since the disease.
- Responsiveness to Levodopa or dopa agonist. This is defined as improvement between Off and On UPDRS by at least 33% of the Motor UPDRS.
- PD of Stage 2.5, 3 \& 4 of HOEHN \& YAHR staging.
Key exclusion criteria (10 listed)
- History of intracranial surgeries or implantation of a device for Parkinson's disease two years prior to treatment.
- History of psychiatric disorders like schizophrenia or psychotic disorders.
- History of other malignancy, with the exception of treated cutaneous squamous cell or basal cell carcinoma, within 5 years.
- Contraindication for MRI
- General medical contraindications for surgery like coagulopathy
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 derived stem cells transplantAlso: stem cells, cell therapy for Parkinson's diseaseStem cells are derived from the bone marrow of the patient and processed at Reliance life sciences.The stem cells are the stereotactically implanted in the striatum. | Procedure or surgery | Therapy for Parkinson's disease |
Primary outcome
Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.
Time frame: Up to 18 months from the day of stem cell transplant.
Results and safety
The study was stopped early (reason given: Adequate no. of patients could not be recruited in the set time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 19467573Arias-Carrion O, Yuan TF. Autologous neural stem cell transplantation: a new treatment option for Parkinson's disease? Med Hypotheses. 2009 Nov;73(5):757-9. doi: 10.1016/j.mehy.2009.04.029. Epub 2009 May 24.
- Individual participant dataSharing planned: No
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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.
Paresh k Doshi, MCh principal investigator
Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Bone marrow derived stem cells transplant in people with Parkinson's Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Aug 2018. 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 India. 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.
Are results available for this study?
The study was stopped early (reason given: Adequate no. of patients could not be recruited in the set time frame.). Results are not available in the source record.
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?
Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests. (time frame: Up to 18 months from the day of stem cell transplant.). 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 NCT00976430, which also lists 1 linked publication.
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 14 Aug 2018.