Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years (BMCP2)

September 16, 2014 updated by: Dr. Sachin Jamadar, Chaitanya Hospital, Pune

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411009
        • Recruiting
        • Chaitnany Hospital
        • Principal Investigator:
          • Dr, Anant E Bagul, MS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intra thecal inj of autologous MNC
Other: Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.
Time Frame: 6 months
- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Improvement in IQ by using Benit Kamat scale.
Time Frame: 6 Months
-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chaitanya Hospital, Pune

Investigators

  • Principal Investigator: Anant E Bagul, M.S., chaitanya stem cell centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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