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

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ClinicalTrials.gov Identifier: NCT01834664
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : April 18, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ataxic Infantile Cerebral Palsy Biological: stem cell (MNCs ) Phase 1 Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
STEM CELL
Transfer of autologous stem cell [MNCs ]intrathecally
 Biological: stem cell (MNCs )
Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval
Other Name: Intra thecal autologous stem cell MNCs


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in muscle rigidity using Ash worth scale [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Improvement in dysregulated phospholipid Metabolism [ Time Frame: 6 months ]
  2. Improvement in walking ability and kinetic gait Pattern [ Time Frame: 6 Months ]
  3. Improvement in overall motor control using oxford scale [ Time Frame: 6 Months ]
  4. Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour [ Time Frame: 6 month ]
  5. Improvement in motor-linked implicit learning [ Time Frame: 6 month ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT01834664


Contacts
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Contact: Sachin S Jamadar, Dortho +918888788880 sac2751982@gmail.com

Locations
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India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin S Jamadar, MBBS.DOrtho    8888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, M.S.Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL
More Information
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Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01834664    
Other Study ID Numbers: 00109
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
Ataxic Infantile Cerebral Palsy stem cell therapy
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases