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Trial record 4 of 53 for:    stem cell Spinal Cord Injury AND Nervous

Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

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: NCT01725880
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : November 14, 2012
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.

Tracking Information
First Submitted Date November 9, 2012
First Posted Date November 14, 2012
Last Update Posted Date June 3, 2016
Study Start Date November 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2012)
American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ]
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01725880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
Official Title Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
Brief Summary The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.
Detailed Description

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.
Condition Spinal Cord Injury
Intervention Other: Observation
Study Groups/Cohorts No treatment
Observation
Intervention: Other: Observation
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 Terminated
Actual Enrollment
 (submitted: November 9, 2012)
12
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
  • Must agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

  • Subjects have received or are receiving off-protocol immunosuppressive medications
  • Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01725880
Other Study ID Numbers CL-N03-SC
TpP_I_2012_002 ( Other Identifier: SwissMedic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party StemCells, Inc.
Study Sponsor StemCells, Inc.
Collaborators Not Provided
Investigators
Study Director: Stephen Huhn, M.D. StemCells, Inc.
PRS Account StemCells, Inc.
Verification Date May 2016