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Trial record 18 of 36 for:    stem cell Spinal Cord Injury AND transplantation

Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163876
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : June 16, 2014
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date June 2, 2016
Study Start Date  ICMJE October 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Change from baseline in ISNCSCI upper extremity motor scores [ Time Frame: Up to one year after enrollment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to one year after enrollment ]
Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale
Change History Complete list of historical versions of study NCT02163876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Number of participants with serious and non-serious adverse events [ Time Frame: Up to one year from the time of enrollment ]
Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
Number of participants with changes in ISNCSCI upper extremity motor scores [ Time Frame: Up to one year from the time of enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
Official Title  ICMJE A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
Brief Summary This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Spinal Cord Injury
  • Spine Injury
  • Cervical Spine Injury
Intervention  ICMJE Drug: HuCNS-SC cells
surgery arm
Other Names:
  • human neural stem cells
  • HuCNS-SC
  • HCNS-SC
Study Arms  ICMJE
  • Experimental: HuCNS-SC cells
    Intramedullary transplantation of HuCNS-SC cells in the cervical spine
    Intervention: Drug: HuCNS-SC cells
  • No Intervention: non-surgery arm
    non-surgery arm
Publications * Ahuja CS, Fehlings M. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury. Stem Cells Transl Med. 2016 Jul;5(7):914-24. doi: 10.5966/sctm.2015-0381. Epub 2016 Apr 29. Review.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2014)
52
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects age 18 to 60 years.
  • Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator.
  • American Spinal Injury Association Impairment Scale (AIS) Grades B or C
  • Minimum of 12 weeks post-injury prior to Screening

Exclusion Criteria:

  • History of penetrating SCI.
  • MRI evidence of complete spinal cord interruption .
  • Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma.
  • Prior participation in another investigational study within 90 days prior to Screening.
  • Previous organ, tissue, bone marrow transplantation, or gene transfer
  • History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02163876
Other Study ID Numbers  ICMJE CL-SCI-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party StemCells, Inc.
Study Sponsor  ICMJE StemCells, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Huhn, MD StemCells, Inc.
PRS Account StemCells, Inc.
Verification Date May 2016

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