Cell Transplant in Spinal Cord Injury Patients

NCT ID: NCT00816803

Last Updated: 2009-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BM transplant with physiotherapy

Autologous BM transplant

Group Type EXPERIMENTAL

Autologous bone marrow transplant

Intervention Type PROCEDURE

Physical therapy

Intervention Type PROCEDURE

Physiotherapy only

conventional physical therapy for chronic spinal cord injury.

Group Type ACTIVE_COMPARATOR

Physical therapy

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous bone marrow transplant

Intervention Type PROCEDURE

Physical therapy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Traumatic spinal cord injury
* No concomitant systemic disease
* No progress on physiotherapy for at least 6 months
* Duration of injury from 10 months to 3 years

Exclusion Criteria

* Non-traumatic spinal cord injury whether transverse myelitis or demyelination
* Concomitant systemic disease
* Progress can be observed on physiotherapy
* Acute injury or duration of injury less than 10 months
Minimum Eligible Age

10 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role collaborator

Medical Military Academy, Egypt

UNKNOWN

Sponsor Role collaborator

Alexandria University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University School of Medicine

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23452836 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EGY-SCI-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.