Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
NCT02034669 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2014-01-13
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.
Conditions
- Acute Spinal Cord Injury
Interventions
- 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
Sponsors & Collaborators
-
Tri Phuoc Biotechnology., JSC
lead OTHER
Principal Investigators
-
Phuc Ba Duong, MD · Tri Phuoc Biotechnology., JSC
-
Hoa D Nguyen, MD · Vietnamese- German Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-12-31
- Completion
- 2015-03-31
Countries
- Vietnam
Study Locations
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