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Clinical Trials/NCT02241395
NCT02241395
Withdrawn
Phase 1

Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy

Neurogen Brain and Spine Institute1 site in 1 countryAugust 2013
ConditionsCerebral Palsy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Neurogen Brain and Spine Institute
Locations
1
Primary Endpoint
change in clinical symptoms over a period of 2 years
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change in GMFM score(1 year)
  • Change in Gross Motor Function Measure(1 year)

Study Sites (1)

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