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

StemCells, Inc

Status: Terminated

Conditions: Spinal Cord Injury

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT01725880

CL-N03-SC

TpP_I_2012_002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

No treatment

Description:

Observation

Treatment:

Other: Observation