MSCs Therapy for Cerebral Palsy

• Sponsor: Aljazeera Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04653077
• Collaborator: AMR KHALIL ORTHOPEDIC SURGERY CENTER (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications	Other: stem cells	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 2, 2020
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Primary Outcome Measures

1. Changes in Motor Performance. [6 months]

   the number of patients who will have changes in motor performance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• 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.

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

Locations

	Site	City	State	Country	Postal Code
1	Aljazeera( Al Gazeera) hospital	Giza		Egypt

Sponsors and Collaborators

• Aljazeera Hospital
• AMR KHALIL ORTHOPEDIC SURGERY CENTER

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aljazeera Hospital
• ClinicalTrials.gov Identifier: NCT04653077
• Other Study ID Numbers: cerebral palsy
• First Posted: Dec 4, 2020
• Last Update Posted: Dec 4, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Dec 4, 2020