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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014