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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01832454
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE April 16, 2013
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01832454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2013)
-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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Other: Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC
Study Arms  ICMJE Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC
Intervention: Other: Intra thecal inj of autologous MNC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 12, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01832454
Other Study ID Numbers  ICMJE 00160
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sachin Jamadar, Chaitanya Hospital, Pune
Study Sponsor  ICMJE Chaitanya Hospital, Pune
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anant E Bagul, M.S. chaitanya stem cell centre
PRS Account Chaitanya Hospital, Pune
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP