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

Ataxic Infantile Cerebral Palsy Clinical Trial

— BMACCP  

Official title:

Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) .It is Self Funded (Patients' Own Funding) Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834664
• Other study ID #: 00109
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 8, 2013
• Last updated: September 16, 2014
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin S Jamadar, Dortho
• Phone: +918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Ataxic Infantile Cerebral Palsy
• Cerebral Palsy

Intervention

Biological:
• stem cell (MNCs )
Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval

Locations

Country	Name	City	State
India	Chaitanya 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		6 Months	Yes
Secondary	Improvement in dysregulated phospholipid Metabolism		6 months	Yes
Secondary	Improvement in walking ability and kinetic gait Pattern		6 Months	Yes
Secondary	Improvement in overall motor control using oxford scale		6 Months	Yes
Secondary	Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour		6 month	Yes
Secondary	Improvement in motor-linked implicit learning		6 month	Yes