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

Cerebral Palsy Clinical Trial

— BMCP2  

Official title:

Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832454
• Other study ID #: 00160
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 26, 2013
• Last updated: September 16, 2014
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC

Locations

Country	Name	City	State
India	Chaitnany Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.	- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.	6 months	Yes
Secondary	-Improvement in IQ by using Benit Kamat scale.	-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.	6 Months	Yes