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

• ClinicalTrials.gov Identifier: NCT01725880
• Recruitment Status: Terminated
• First Posted: November 14, 2012
• Last Update Posted: June 3, 2016
• Sponsor: StemCells, Inc.
• 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

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

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