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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE September 12, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
change in clinical symptoms over a period of 2 years [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT02241395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2014)
  • Change in GMFM score [ Time Frame: 1 year ]
  • Change in Gross Motor Function Measure [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cell Therapy as Treatment for Cerebral Palsy
Official Title  ICMJE Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Biological: Intrathecal autologous bone marrow mononuclear cell transplantation
Study Arms  ICMJE Experimental: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation
Intervention: Biological: Intrathecal autologous bone marrow mononuclear cell transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2014)
500
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02241395
Other Study ID Numbers  ICMJE NGBSI-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurogen Brain and Spine Institute
Study Sponsor  ICMJE Neurogen Brain and Spine Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Neurogen Brain and Spine Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP