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MSCs Therapy 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04653077
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
AMR KHALIL ORTHOPEDIC SURGERY CENTER
Information provided by (Responsible Party):
Aljazeera Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Complications Other: stem cells Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bone Marrow Stem Cells Transplantation for the Treatment of Cerebral Palsy
Estimated Study Start Date : December 2, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Motor Performance. [ Time Frame: 6 months ]
    the number of patients who will have changes in motor performance


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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653077


Contacts
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Contact: amr khalil 01223292124 amrkhalil273@gmail.com

Locations
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Egypt
Aljazeera( Al Gazeera) hospital
Giza, Egypt
Contact: Mahmoud Alalfy, PhD    +201002611058 ext +2    mahmoudalalfy@ymail.com   
Sponsors and Collaborators
Aljazeera Hospital
AMR KHALIL ORTHOPEDIC SURGERY CENTER
More Information
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Responsible Party: Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT04653077    
Other Study ID Numbers: cerebral palsy
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases