Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

This study has suspended participant recruitment.
(Adequate no. of patients could not be recruited in the set time frame.)
Sponsor:
Information provided by (Responsible Party):
Dr Paresh Doshi, Jaslok Hospital and Research Centre
ClinicalTrials.gov Identifier:
NCT00976430
First received: September 11, 2009
Last updated: September 17, 2013
Last verified: September 2013

September 11, 2009
September 17, 2013
July 2009
November 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00976430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 May 23; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
5
Not Provided
November 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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00976430
JHC525
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
September 2013

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