search
Back to results

Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Autologous Bone marrow derived stem cells transplant
Sponsored by
Jaslok Hospital and Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Autologous Stem Cells.

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaslok Hospital And Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapy for Parkinson's disease

Arm Description

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.

Outcomes

Primary Outcome Measures

Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
August 12, 2018
Sponsor
Jaslok Hospital and Research Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT00976430
Brief Title
Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease
Official Title
To Study the Safety and Efficacy of Bone Marrow Derived Mesenchymal Stem Cells Transplant in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Adequate no. of patients could not be recruited in the set time frame.
Study Start Date
July 2009 (Actual)
Primary Completion Date
November 30, 2011 (Actual)
Study Completion Date
April 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaslok Hospital and Research Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Autologous Stem Cells.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy for Parkinson's disease
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Autologous Bone marrow derived stem cells transplant
Other Intervention Name(s)
stem cells, cell therapy for Parkinson's disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh k Doshi, MCh
Organizational Affiliation
Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaslok Hospital And Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19467573
Citation
Arias-Carrion 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.
Results Reference
background

Learn more about this trial

Autologous Mesenchymal Stem Cell Transplant for Parkinson's Disease

We'll reach out to this number within 24 hrs