Clinical trial NCT00976430: 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
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Autologous Stem Cells.
Lead sponsor: Jaslok Hospital and Research Centre
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 5
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in clinical condition of the patient assessed using UPDRS (UNIFIED PARKINSON'S DISEASE RATING SCALE) and Time Tests.
timeFrame: Up to 18 months from the day of stem cell transplant.
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Jaslok Hospital And Research Centre
state: Maharashtra
Study officials:
affiliation: Incharge Stereotactic and functional Neurosurgery,Jaslok Hospital and Research Centre.
name: Paresh k Doshi, MCh
role: PRINCIPAL_INVESTIGATOR
References:
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.