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Cell Therapy as Treatment for Cerebral Palsy

This study is currently recruiting participants.
Verified September 2017 by Neurogen Brain and Spine Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02241395
First Posted: September 16, 2014
Last Update Posted: September 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
  Purpose
The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.

Condition Intervention Phase
Cerebral Palsy Biological: Intrathecal autologous bone marrow mononuclear cell transplantation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Mononuclear Cell Therapy 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 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:
  • Change in GMFM score [ Time Frame: 1 year ]
  • Change in Gross Motor Function Measure [ Time Frame: 1 year ]

Estimated Enrollment: 500
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation
Biological: Intrathecal autologous bone marrow mononuclear cell transplantation

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT02241395     History of Changes
Other Study ID Numbers: NGBSI-09
First Submitted: September 12, 2014
First Posted: September 16, 2014
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