Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Transplantation of Purified Autologous Bone Marrow- or Leukapheresis-Derived CD34+ and CD133+ for Patients With Spinal Cord Injuries: A Long-Term Comparative Evaluation of Safety and Efficacy Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02687672
• Other study ID #: SCA-SCI1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Stem Cells Arabia
• Contact: Adeeb AlZoubi, PhD
• Phone: 00962795337575
• Email: adeebalzoubi[@]stemcellsarabia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.

Description:

Spinal cord injury (SCI) leads to apoptosis of oligodendrocytes at the injury site resulting in demyelination and neuronal degeneration. This degeneration causes severe functional sensory and motor mutilations that remain an immense challenge to physicians and in which stem cell (SC) transplantation represents a viable alternative. This study is a phase I/II trial aimed at describing a method for treating patients with chronic complete spinal cord injuries (SCI) by utilizing autologous, purified CD34+ and CD133+ stem cells (SCs). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells in treated patients during a 5-year follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients suffering from chronic spinal cord injury

• Age of injury ranging from 6-60 months prior to enrollment in this study.

• Ability and willingness to regularly visit Jordan Orthopedic and Spinal Center for post operation follow up.

• Traumatic Injury of spinal cord with complete or partial damage confirmed by MRI.

Exclusion Criteria:

• Injuries less than 6 months old or more than 60 months old

• Non-traumatic injuries (SCI due to inflammation, autoimmune diseases)

• Patients less than 5 or older than 50 years

• Patients suffering from other conditions, including chronic neurological diseases, diabetes mellitus, cardiac/kidney/liver disorders, previous strokes, and previous surgeries unrelated to spinal cord injury.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• Stem Cell Transplantation
Transplantation of autologous stem cells

Locations

Country	Name	City	State
Jordan	Stem Cells Arabia	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)		60 months
Secondary	Improvement in urine and stool incontinence using a questionnaire		6 months
Secondary	Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire		6 months
Secondary	Improvement in quality of life using a questionnaire		6 months
Secondary	Improvement in personal independence and productivity using questionnaire		6 months