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Bone Marrow-Derived Stem Cell Transplantation for the Treatment of 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: NCT03078621
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Stem Cells Arabia

Brief Summary:
This study is a single arm, single center trial to study the safety and efficacy of purified autologous bone marrow derived stem cells and mesenchymal stem cells for the treatment of children with cerebral palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: Stem Cell Therapy Phase 1 Phase 2

Detailed Description:

Cerebral palsy (CP) is a chronic childhood disorder defined by a range of motor and cognitive impairments and results in a substantial suffering to the patient and a tremendous socio-economic burden to the individual, family, and healthcare system. With no effective treatments or interventions, therapies for CP are currently focused on supportive and management strategies. Stem cell transplantation has been suggested as a putative intervention for neural pathology, as mesenchymal and neural stem cells, as well as olfactory ensheathing glia and Schwann cells, which have shown some regenerative and functional efficacy in experimental central nervous system disorders.

In this trial, the investigators study the safety and efficacy of the intrathecal transplantation of specific populations of purified autologous bone marrow-derived stem cells and mesenchymal stem cells in patients with cerebral palsy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Transplantation of Specific Populations of Stem Cells and Mesenchymal Stem Cells for the Treatment of Cerebral Palsy
Study Start Date : September 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stem Cells
Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.
Biological: Stem Cell Therapy
Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells.

Primary Outcome Measures :
  1. Changes in Motor Performance. [ Time Frame: 6 months ]
    GMPM (Gross Motor Performance Measure) as a standard measurement tool for assessing quality of movement.

Secondary Outcome Measures :
  1. Motor function studies [ Time Frame: 1 year ]
    Total volumes and specific tract lesions will be studied and correlated with functional outcomes.

  2. Specific white matter tract analysis using MRI [ Time Frame: 6 months ]
    Changes on brain Diffusion Tensor Image (DTI).

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study.
  • Clinical evidence of a non-progressive motor disability due to brain dysfunction.
  • Willing to comply with all study procedures.
  • Gross Motor Function Classification Score level II-V

Exclusion Criteria:

Known history of:

  • Intractable seizures
  • Traumatic brain injury
  • Genetic disorder
  • Current Infection
  • Renal insufficiency
  • Hepatic disease
  • HIV+ (as demonstrated by positive blood test)
  • Immunosuppression
  • Infectious related neurological injury
  • Other etiologies such as degenerative, mitochondrial, and metabolic disorders
  • Normal brain MRI
  • Evidence of acute illness such as fever (temperature > 37.5 C), vomiting, diarrhea, wheezing or crackles
  • Progressing neurological disease (Batten Disease, Leukodystrophies, Neurotransmitter disorders)
  • Microcephaly, macrocephaly, cortical malformations, or genetic disorders of dysgenesis
  • Pulmonary disease requiring ventilator support
  • Unwillingness to return for follow-up visits
  • Contraindications to MRI

Responsible Party: Stem Cells Arabia
ClinicalTrials.gov Identifier: NCT03078621     History of Changes
Other Study ID Numbers: SCA-CP1
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stem Cells Arabia:
stem cells

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