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

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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

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Intra thecal inj of autologous MNC Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : March 2011
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC
Other: Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. -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.



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832454


Locations
India
Chaitnany Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin A Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Dr, Anant E Bagul, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
Principal Investigator: Anant E Bagul, M.S. chaitanya stem cell centre

Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01832454     History of Changes
Other Study ID Numbers: 00160
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
cerebral palsy stem cells [MNCS]

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases