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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01725880
• Other study ID #: CL-N03-SC
• Secondary ID: TpP_I_2012_002
• Status: Terminated
• Phase: N/A
• First received: November 9, 2012
• Last updated: June 1, 2016
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: StemCells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Observation

Locations

Country	Name	City	State
Switzerland	Uniklinik Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
StemCells, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Spinal Injury Association (ASIA) Impairment Scale Improvement	Evidence of improvement in ASIA impairment scale as confirmed by neurological examination	Four years	No