Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
This study is enrolling participants by invitation only.
Sponsor:
StemCells, Inc.
Information provided by (Responsible Party):
StemCells, Inc.
ClinicalTrials.gov Identifier:
NCT01725880
First received: November 9, 2012
Last updated: January 13, 2015
Last verified: January 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Other: Observation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by StemCells, Inc.:
Primary Outcome Measures:
- American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ] [ Designated as safety issue: No ]Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
No treatment
Observation
|
Other: Observation |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725880
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725880
Locations
| Switzerland | |
| Uniklinik Balgrist | |
| Zurich, Switzerland, 8008 | |
Sponsors and Collaborators
StemCells, Inc.
Investigators
| Study Director: | Stephen Huhn, M.D. | StemCells, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | StemCells, Inc. |
| ClinicalTrials.gov Identifier: | NCT01725880 History of Changes |
| Other Study ID Numbers: | CL-N03-SC, TpP_I_2012_002 |
| Study First Received: | November 9, 2012 |
| Last Updated: | January 13, 2015 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by StemCells, Inc.:
|
Spinal Cord Injury HuCNS-SC cells Human Neural Stem Cells Neural Stem Cells Stem Cells |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases |
Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on March 03, 2015