Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Procedure: Autologous Bone marrow derived stem cells transplant

• Registration Number: NCT00976430
• Lead Sponsor: Jaslok Hospital and Research Centre

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 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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2011-11-30
• Study Completion: 2012-04-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapy for Parkinson's disease	Autologous Bone marrow derived stem cells transplant	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.

Primary Outcome Measures

Name	Time	Method
Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.	Up to 18 months from the day of stem cell transplant.

Trial Locations

Locations (1)

Jaslok Hospital And Research Centre; 🇮🇳 Mumbai, Maharashtra, India