Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years

Phase 2

• Conditions: Cerebral Palsy
• Interventions: Other: Intra thecal inj of autologous MNC

• Registration Number: NCT01832454
• Lead Sponsor: Chaitanya Hospital, Pune

Brief Summary

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed Description

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

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

Inclusion Criteria

• Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
• Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
• 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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
• Hemodynamically unstable patients
• history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
• peripheral Muscular dystropy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra thecal inj of autologous MNC	Intra thecal inj of autologous MNC	Intra thecal inj of autologous MNC

Primary Outcome Measures

Name	Time	Method
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.	6 months	- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.

Secondary Outcome Measures

Name	Time	Method
-Improvement in IQ by using Benit Kamat scale.	6 Months	-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.

Trial Locations

Locations (1)

Chaitnany Hospital; 🇮🇳 Pune, Maharashtra, India