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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 16, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 17, 2020
March 1, 2020
5.4 years
February 16, 2016
March 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association)
60 months
Secondary Outcomes (4)
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
Study Arms (2)
Stem Cell Transplantation
EXPERIMENTALInjection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
Stem Cells
EXPERIMENTALInjection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.
Interventions
Transplantation of autologous stem cells
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cells Arabia
Amman, 11953, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2016
First Posted
February 22, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
March 17, 2020
Record last verified: 2020-03