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
  Purpose

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.


Condition Intervention
Parkinson's Disease
Procedure: Autologous Bone marrow derived stem cells transplant

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Jaslok Hospital and Research Centre:

Primary 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: July 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976430

Locations
India
Jaslok Hospital And Research Centre
Mumbai, Maharashtra, India, 400026
Sponsors and Collaborators
Jaslok Hospital and Research Centre
Investigators
Principal Investigator: Paresh k Doshi, MCh Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
  More Information

Publications:
Responsible Party: Dr Paresh Doshi, In-charge Stereotactic and Functional neurosurgery, Jaslok Hospital and Research Centre
ClinicalTrials.gov Identifier: NCT00976430     History of Changes
Other Study ID Numbers: JHC525
Study First Received: September 11, 2009
Last Updated: September 17, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Jaslok Hospital and Research Centre:
Autologous Stem Cells.

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 29, 2014