Status:
TERMINATED
Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease
Lead Sponsor:
Jaslok Hospital and Research Centre
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief 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.
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 tr...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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.
- Exclusion Criteria:
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00976430
Start Date
July 1 2009
End Date
April 30 2012
Last Update
August 14 2018
Active Locations (1)
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1
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, India, 400026