Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976430
Recruitment Status : Suspended (Adequate no. of patients could not be recruited in the set time frame.)
First Posted : September 14, 2009
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
Dr Paresh Doshi, Jaslok Hospital and Research Centre

September 11, 2009
September 14, 2009
March 9, 2017
July 2009
November 30, 2011   (Final data collection date for 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. ]
Same as current
Complete list of historical versions of study NCT00976430 on Archive Site
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Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease
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.

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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
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.
Other Names:
  • stem cells
  • cell therapy for Parkinson's disease
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.
Intervention: Procedure: Autologous Bone marrow derived stem cells transplant
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
Not Provided
November 30, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Dr Paresh Doshi, Jaslok Hospital and Research Centre
Jaslok Hospital and Research Centre
Not Provided
Principal Investigator: Paresh k Doshi, MCh Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
Jaslok Hospital and Research Centre
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP