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.
Full Title of Study: “To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson’s Disease”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 30, 2011
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.
- Procedure: Autologous Bone marrow derived stem cells transplant
- 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.
Arms, Groups and Cohorts
- Experimental: Therapy for Parkinson’s disease
- 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.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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.
- 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
Gender Eligibility: All
Minimum Age: 35 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Jaslok Hospital and Research Centre
- Provider of Information About this Clinical Study
- Principal Investigator: Dr Paresh Doshi, In-charge Stereotactic and Functional neurosurgery – Jaslok Hospital and Research Centre
- Overall Official(s)
- Paresh k Doshi, MCh, Principal Investigator, Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
Arias-Carrión 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.
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