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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.
 
ClinicalTrials.gov Identifier: NCT00976430
Recruitment Status : Terminated (Adequate no. of patients could not be recruited in the set time frame.)
First Posted : September 14, 2009
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Paresh Doshi, Jaslok Hospital and Research Centre

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date August 14, 2018
Actual Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 30, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease
Official Title  ICMJE To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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
Study Arms  ICMJE 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2012
Actual Primary Completion Date November 30, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976430
Other Study ID Numbers  ICMJE JHC525
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Paresh Doshi, Jaslok Hospital and Research Centre
Study Sponsor  ICMJE Jaslok Hospital and Research Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paresh k Doshi, MCh Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
PRS Account Jaslok Hospital and Research Centre
Verification Date August 2018

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