Clinical study on the use of ex vivo expanded allogeneic mesenchymal stem cells for Parkinson's disease

• Conditions: Parkinson's Disease

• Registration Number: CTRI/2010/091/000432
• Lead Sponsor: ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A" Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)

Brief Summary

This study has been designed as an open label, non-randomized, uncontrolled, prospective, single center, pilot study. The subject will receive ex-vivo expanded bone marrow derived allogeneic mesenchymal stem cells at the dose of 4million cells/Kg body weight. First dose will be given through precoronal burr hole surgery after baseline studies are over. Source of cells: The mesenchymal stem cells would be derived from the Bone marrow of an adult healthy donor after appropriate screening and informed consent. Method of expansion: The sample would be centrifuged and the cell suspension separated using density gradient technique to isolate the mononuclear stem cells ( MNCs) .From the MNC fraction, mesenchymal stem cells will be further isolated using plastic adhesion technique and expanded in vitro to obtain the required number of cells for intervention. The cells would be further quality tested as per ISCT (International Society for Cellular Therapy) guidelines before release for clinical intervention.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

• Inclusion of patients for therapy will be under the investigator's discretion.
• However the following criteria will be considered.1. Should be in the age group of 18-80 years.2. Should be fully conscious, alert and oriented while providing consent3.
• Should show significant motor and non motor symptoms4.
• Subject should understand the requirements of study5.
• Subject should provide a written informed consent and agree to return for Follow up6.
• Subject should be clinically diagnosed for Parkinson's disease with motor complications despite adequate oral anti-parkisonian therapy.7. Should be able to comply with and understand the required visit schedule and complete the same.

Exclusion Criteria

• Exclusion of patients from therapy will be under the investigator's discretion.
• However the following criteria will be considered1.
• Patient is suffering from Dementia (MMSE <25)2.
• Patient is suffering from a neurodegenerative disorder other than Parkinson.3. The extent or severity of the disease is not measurable.4. If the subject suffers from pre-existing medical conditions such as bleeding disorders, septicemia.5. Patients with a past (within one year) or present history of psychiatric disorder.6. If the subject has been enrolled in other investigational drug trial or has completed any trial within the last 3 months.7. If Hemoglobin < 10gm/dl, Serum Creatinine< 2mg/dl serum total bilirubin< 2mg /dl and HbA1c<7?8.
• Pregnant or nursing or women in child bearing age without adequate contraception.9. The subject tested positive for HIV, HCV, HBV,or VDRL.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome measures:1At 1, 3, 6 and 12 months after discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. 2Clinical improvement will be defined as a decrease in the specific symptom and lesions. 3UPDRS will be repeated in all patients. Apart from the routine Proforma for Parkinsonism, the UPDRS will be done at the baseline and at the 12th month.4Safety and tolerability, assessed by adverse events5Quality of life	3,6,9,12 months

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome will be the change in the baseline in UPDRS.	3,6,9,12 months

Trial Locations

Locations (1)

BGS-GLOBAL HOSPITAL; 🇮🇳 Bangalore, KARNATAKA, India

BGS-GLOBAL HOSPITAL

🇮🇳Bangalore, KARNATAKA, India

Dr. Abhilash Bansal

Principal investigator

80-26255555

abhilashbansal@hotmail.com