NCT04653077

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

December 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

November 27, 2020

Last Update Submit

November 27, 2020

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

  • Changes in Motor Performance.

    the number of patients who will have changes in motor performance

    6 months

Study Arms (1)

stem cells

EXPERIMENTAL

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

Other: stem cells

Interventions

stem cellsOTHER

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

stem cells

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical evidence of a non-progressive motor disability due to brain dysfunction.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

Central Study Contacts

amr khalil

CONTACT

01223292124amrkhalil273@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2020

First Posted

December 4, 2020

Study Start

December 2, 2020

Primary Completion

October 15, 2022

Study Completion

December 1, 2022

Last Updated

December 4, 2020

Record last verified: 2020-11

Locations

EG(1)