Clinical study on the use of ex vivo expanded Allogenic Mesenchymal Stem Cells for Cerebral Palsy

• Conditions: Cerebral Palsy

• Registration Number: CTRI/2010/091/000435
• Lead Sponsor: ADVANCED NEURO-SCIENCE ALLIES PVT. LTD#560, Bhargavi, 9th "A' Main, Indiranagar, Bangalore-560 038Karnataka (INDIA)

Brief Summary

The study has been designed as an Open labelled, Non-randomized, Un-controlled, Prospective, Single center, Pilot study .After initial screening ( as per inclusion/exclusion criteria) and post recruitment, the subject will undergo all baseline tests ( as described). Subsequent to baseline tests, he/she will receive ex-vivo expanded allogeneic mesenchymal stem cells (4million cells/Kg body weight) intra-cranially (bilateral pre-coronal burr hole surgery) at a single centre in India. 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 investigators discretion.
• However the following criteria will be considered.- Must be more than 2 years of age and less than 15 years of age at the time of screening for inclusion in the study.- Clinical evidence of a non-progressive motor disability due to brain dysfunction.
• The subjects will not have the ability to sit independently by one year of age or the ability to walk by 18 months of age.- Willing to comply with all study procedures.- The patients must be seizure-free or seizures adequately controlled.
• If there is a suspicion of seizures and EEG should be done prior to inclusion.

Exclusion Criteria

• Exclusion of patients from therapy will be under the investigator?s discretion.
• However the following criteria will be considered1.
• Have complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely2.
• Presence of obstructive hydrocephalus.3. Presence of progressive neurological disease.4. Presence of known chromosomal anomaly5.
• Presence of major congenital anomaly6.
• Evidence of illness on planned infusion date (such as but not limited to fever >38.5, vomiting, diarrhea, wheezing, or crackles)7.
• Use of immunosuppressive drugs8.
• Evidence of known genetic disorder.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
After discharge, patients will have follow-up examinations to assess their clinical status and to review their current medication. 1. Clinical improvement will be defined as a decrease in the specific symptom and/or lesions. 2. Safety and tolerability, assessed by adverse events 3. Quality of life 4. Neuropyschological tests to assess the IQ in these children. 5. Appropriate tests to record Renal function tests, Liver function tests at the end of the study.	3,6, 9, 12 months

Secondary Outcome Measures

Name	Time	Method
Confirm the efficacy of allogenic mesenchymal stem cells infusion in children with cerebral palsy using patient questionnaire and standardized gross Motor Function Measures evaluation	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