MSCs Therapy for Cerebral Palsy

November 27, 2020 updated by: Aljazeera Hospital

Bone Marrow Stem Cells Transplantation for the Treatment of Cerebral Palsy

Cerebral palsy (CP) is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that are the result of a non-progressive disruption or injury that occurred during fetal brain development or within the first two years of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This disruption can result in spasticity, dystonia, muscle contractures, weakness and difficulty in coordination that ultimately affects the ability to control movements. Resultant activity limitations may affect gross motor movements, fine motor movements, speech and communication, as well as eating and drinking.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Aljazeera( Al Gazeera) hospital

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.

Exclusion Criteria:

  • • Intractable seizures

    • Traumatic brain injury
    • Genetic disorder
    • Current Infection
    • Renal insufficiency
    • Hepatic disease
    • HIV+ (as demonstrated by positive blood test)
    • Immunosuppression

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: stem cells
Intravenous and Intrathecal transplantation of specific populations of purified 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
the number of patients who will have changes in motor performance
6 months

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Collaborators

AMR KHALIL ORTHOPEDIC SURGERY CENTER

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 (Anticipated)

December 2, 2020

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

November 27, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cerebral Palsy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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