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

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ClinicalTrials.gov Identifier: NCT02687672
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Stem Cells Arabia

Tracking Information
First Submitted Date  ICMJE February 16, 2016
First Posted Date  ICMJE February 22, 2016
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
Overall clinical improvement in sensory and motor functions using ASIA (American Spinal Cord Injury Association) [ Time Frame: 60 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02687672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • Improvement in urine and stool incontinence using a questionnaire [ Time Frame: 6 months ]
  • Functional improvement in impotence and previous sexual erection status (male patients) using a questionnaire [ Time Frame: 6 months ]
  • Improvement in quality of life using a questionnaire [ Time Frame: 6 months ]
  • Improvement in personal independence and productivity using questionnaire [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Biological: Stem Cell Transplantation
Transplantation of autologous stem cells
Study Arms  ICMJE
  • Experimental: Stem Cell Transplantation
    Injection of leukapheresis-derived, purified, autologous CD34+and CD133+ stem cells
    Intervention: Biological: Stem Cell Transplantation
  • Experimental: Stem Cells
    Injection of bone marrow-derived, purified, autologous CD34+and CD133+ stem cells.
    Intervention: Biological: Stem Cell Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adeeb AlZoubi, PhD 00962795337575 adeebalzoubi@stemcellsarabia.net
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02687672
Other Study ID Numbers  ICMJE SCA-SCI1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stem Cells Arabia
Study Sponsor  ICMJE Stem Cells Arabia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stem Cells Arabia
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP