NCT02034669

Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment

A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Tri Phuoc Biotechnology., JSC · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety and effect of autologous adipose derived stem cell (ADSCs) transplantation in acute spinal cord injury patients. 1. To assess the safety of autologous ADSCs transplantation in acute spinal cord injury and the complication after ADSCs transplantation. 2. To evaluate the effect of ADSCs isolation and expansion procedure. 3. To determine if functional outcome is improved following ADSCs transplantation in acute spinal cord injury patient, using pre-transplantation spinal cord function as the control.

Detailed description

The research has carried out in Phase II which is designed as randomized controlled trials. Selection of patients began in Feb,2013, 48 patients are divided in two group according to a 2:1 ratio (the number of candidates as treated: the candidates as control). The effectiveness of preliminary trial are evaluated by assessing Frankel/ASIA motor grade, measuring electrophysiological parameters, enhanced MRI and urinary and bowel function.

Conditions

• Acute Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Laminectomy	surgical laminectomy with glial scar resection
DEVICE	Intradural space	ADSCs injection into Intradural space at damage site
DEVICE	Intrathecal	ADSCs Intrathecal into lumbar puncture
DEVICE	Intravenous	ADSCs intravenous

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2014-01-13
• Last updated: 2014-01-13

Locations

1 site across 1 country: Vietnam