Clinical trial NCT02687672: Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Stem Cells Arabia
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
timeFrame: 60 months
Secondary outcomes:
measure: Improvement in urine and stool incontinence using a questionnaire
timeFrame: 6 months
measure: Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire
timeFrame: 6 months
measure: Improvement in quality of life using a questionnaire
timeFrame: 6 months
measure: Improvement in personal independence and productivity using questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Stem Cells Arabia
Study officials:
References: