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

Stem Cells Arabia

Status and phase: Unknown; Phase 2

Conditions: Spinal Cord Injury

Treatments: Biological: Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02687672

SCA-SCI1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Stem Cell Transplantation

Experimental group

Description:

Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells

Treatment:

Biological: Stem Cell Transplantation

Stem Cells

Experimental group

Description:

Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.

Treatment:

Biological: Stem Cell Transplantation