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MSCs Therapy for Cerebral Palsy

Primary Purpose

Stem Cell Transplant Complications

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stem cells
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stem Cell Transplant Complications

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aljazeera( Al Gazeera) hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cells

Arm Description

Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.

Outcomes

Primary Outcome Measures

Changes in Motor Performance.
the number of patients who will have changes in motor performance

Secondary Outcome Measures

Full Information

First Posted
November 27, 2020
Last Updated
November 27, 2020
Sponsor
Aljazeera Hospital
Collaborators
AMR KHALIL ORTHOPEDIC SURGERY CENTER
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1. Study Identification

Unique Protocol Identification Number
NCT04653077
Brief Title
MSCs Therapy for Cerebral Palsy
Official Title
Bone Marrow Stem Cells Transplantation for the Treatment of Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2020 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
Collaborators
AMR KHALIL ORTHOPEDIC SURGERY CENTER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stem cells
Arm Type
Experimental
Arm Description
Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.
Intervention Type
Other
Intervention Name(s)
stem cells
Intervention Description
Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.
Primary Outcome Measure Information:
Title
Changes in Motor Performance.
Description
the number of patients who will have changes in motor performance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr khalil
Phone
01223292124
Email
amrkhalil273@gmail.com
Facility Information:
Facility Name
Aljazeera( Al Gazeera) hospital
City
Giza
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Phone
+201002611058
Ext
+2
Email
mahmoudalalfy@ymail.com

12. IPD Sharing Statement

Learn more about this trial

MSCs Therapy for Cerebral Palsy

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