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Cell Therapy as Treatment for Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02241395
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Study Description
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Brief Summary:
The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: Intrathecal autologous bone marrow mononuclear cell transplantation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy
Study Start Date : August 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation
 Biological: Intrathecal autologous bone marrow mononuclear cell transplantation


Outcome Measures
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Primary Outcome Measures :
  1. change in clinical symptoms over a period of 2 years [ Time Frame: 2 years ]
    Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc


Secondary Outcome Measures :
  1. Change in GMFM score [ Time Frame: 1 year ]
  2. Change in Gross Motor Function Measure [ Time Frame: 1 year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Months to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed cases of any type of Cerebral Palsy
  • age above 6 months.

Exclusion Criteria:

  • presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus
  • malignancies
  • bleeding tendencies
  • pneumonia
  • renal failure
  • severe liver dysfunction
  • severe anemia [Hemoglobin < 8]
  • any bone marrow disorder
  • space occupying lesion in brain
  • other acute medical conditions such as respiratory infection and pyrexia.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02241395


Locations
India
Neurogen brain and spine institute Recruiting
Navi Mumbai, Maharashtra, India, 400706
Contact: Alok K Sharma, M.S, M.Ch    022-25283706    alok276@gmail.com   
Principal Investigator: Alok K Sharma, M.S, M.Ch         
Sponsors and Collaborators
Neurogen Brain and Spine Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02241395     History of Changes
Other Study ID Numbers: NGBSI-09
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Neurogen Brain and Spine Institute:
Cerebral Palsy
autologous bone marrow mononuclear cells
stem cell

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