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Cell Therapy as Treatment for Cerebral Palsy

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: NCT02241395
Recruitment Status : Withdrawn
First Posted : September 16, 2014
Last Update Posted : October 25, 2018
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)
Actual Enrollment : 0 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


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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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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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
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India
Neurogen brain and spine institute
Navi Mumbai, Maharashtra, India, 400706
Sponsors and Collaborators
Neurogen Brain and Spine Institute
More Information
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Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02241395    
Other Study ID Numbers: NGBSI-09
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Keywords provided by Neurogen Brain and Spine Institute:
Cerebral Palsy
autologous bone marrow mononuclear cells
stem cell
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