None listed
Conditions
Interventions
Intervention1: bilateral precoronal burr hole: 4 million cells/kg body weight
Control Intervention1: NIL: NIL
Sponsors
ADVANCED NEURO-SCIENCE ALLIES PVT. LTD
#560, Bhargavi, 9th "A' Main, Indiranagar,
Bangalore-560 038
Karnataka (INDIA)
Eligibility
Inclusion criteria
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 criteria: Exclusion of patients from therapy will be under the investigator?s discretion. However the following criteria will be considered 1. Have complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely 2. Presence of obstructive hydrocephalus. 3. Presence of progressive neurological disease. 4. Presence of known chromosomal anomaly 5. Presence of major congenital anomaly 6. 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 drugs 8. Evidence of known genetic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 3,6, 9, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirm the efficacy of allogenic mesenchymal stem cells infusion in children with cerebral palsy using patient questionnaire and standardized gross Motor Function Measures evaluationTimepoint: 3,6,9,12 months | — |
Countries
India
Contacts
Public ContactMrs. Vijayalakshmi
Outcome results
None listed