Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years

Phase 1

• Conditions: Ataxic Infantile Cerebral Palsy
• Interventions: Biological: stem cell (MNCs )

• Registration Number: NCT01834664
• Lead Sponsor: Chaitanya Hospital, Pune

Brief Summary

This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed Description

Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
• Patient suffer from cerebral palsy due to prenatal and postnatal cause,
• Willing to undergoing Bone Marrow derived autologous stem cell therapy.
• Able to Comprehend and give written informed consent form for the study
• willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria

• History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
• Hemodynamically unstable patients
• history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
• peripheral Muscular dystrophy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEM CELL	stem cell (MNCs )	Transfer of autologous stem cell \[MNCs \]intrathecally

Primary Outcome Measures

Name	Time	Method
Improvement in muscle rigidity using Ash worth scale	6 Months

Secondary Outcome Measures

Name	Time	Method
Improvement in motor-linked implicit learning	6 month
Improvement in overall motor control using oxford scale	6 Months
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour	6 month
Improvement in dysregulated phospholipid Metabolism	6 months
Improvement in walking ability and kinetic gait Pattern	6 Months

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India