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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02687672

Enrollment

Registered

2016-02-22

Start date

2016-01-31

Completion date

2021-12-31

Last updated

2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Brief 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.

Detailed 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.

Interventions

BIOLOGICALStem Cell Transplantation

Transplantation of autologous stem cells

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)	60 months

Secondary

Measure	Time frame
Improvement in urine and stool incontinence using a questionnaire	6 months
Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire	6 months
Improvement in quality of life using a questionnaire	6 months
Improvement in personal independence and productivity using questionnaire	6 months

Countries

Jordan

Contacts

Primary ContactAdeeb AlZoubi, PhD

adeebalzoubi@stemcellsarabia.net00962795337575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026