Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy

March 15, 2020 updated by: Stem Cells Arabia

Safety and Efficacy of Transplantation of Specific Populations of Stem Cells and Mesenchymal Stem Cells for the Treatment of Cerebral Palsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function studies
Time Frame: 1 year
Total volumes and specific tract lesions will be studied and correlated with functional outcomes.
1 year
Specific white matter tract analysis using MRI
Time Frame: 6 months
Changes on brain Diffusion Tensor Image (DTI).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cells Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (ACTUAL)

March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA-CP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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