Stem Cell Therapy for Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT01978821
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

the purpose of this study was to study the effect of stem cell therapy on common symptoms of cerebral palsy patients.


Condition Intervention Phase
Cerebral Palsy
Procedure: Autologous bone marrow mononuclear cell transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Neurogen Brain and Spine Institute:

Primary Outcome Measures:
  • Change in clinical symptoms of cerebral palsy after 6 months [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stem cell
autologous bone marrow mononuclear cell transplantation
Procedure: Autologous bone marrow mononuclear cell transplantation

  Eligibility

Ages Eligible for Study:   17 Months to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed cases of any type of Cerebral Palsy
  • age above 12 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978821

Locations
India
Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
  More Information

Additional Information:
Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT01978821     History of Changes
Other Study ID Numbers: NGBSI-01
Study First Received: October 25, 2013
Last Updated: October 31, 2013
Health Authority: India: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 15, 2014