Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
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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
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Condition or disease | Intervention/treatment |
---|---|
Spinal Cord Injury | Other: Observation |
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 |
Actual Enrollment : | 12 participants |
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 |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Group/Cohort | Intervention/treatment |
---|---|
No treatment
Observation
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Other: Observation |
- American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ]Evidence of improvement in ASIA impairment scale as confirmed by neurological examination

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725880
Switzerland | |
Uniklinik Balgrist | |
Zurich, Switzerland, 8008 |
Study Director: | Stephen Huhn, M.D. | StemCells, Inc. |
Responsible Party: | StemCells, Inc. |
ClinicalTrials.gov Identifier: | NCT01725880 |
Other Study ID Numbers: |
CL-N03-SC TpP_I_2012_002 ( Other Identifier: SwissMedic ) |
First Posted: | November 14, 2012 Key Record Dates |
Last Update Posted: | June 3, 2016 |
Last Verified: | May 2016 |
Spinal Cord Injury HuCNS-SC cells Human Neural Stem Cells Neural Stem Cells Stem Cells |
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |