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

Phase 1

• Conditions: Acute Spinal Cord Injury
• Interventions: Device: Laminectomy; Device: Intradural space; Device: Intrathecal; Device: Intravenous

• Registration Number: NCT02034669
• Lead Sponsor: Tri Phuoc Biotechnology., JSC

Brief 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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-10
• Last Update Submitted: 2014-01-10
• Study First Posted: 2014-01-13
• Last Update Posted: 2014-01-13
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Must be able to give voluntary (patients may not be able to write) consent.
• Must be able to understand study information provided to him.
• Patients with complete spinal cord < 2 weeks in acute category
• The level of spinal cord injury must be categorized at A level in terms of ASIA Impairment scale.
• Age should be between 19-60 years
• Both male and female

Exclusion Criteria

• Support respiration by machine
• Melanoma within 5 years
• Infectious diseases including HIV and Hepatitis B, C
• Brain damage or multiple trauma
• Body temperature higher 38 ℃ or acute disorder
• Anemia or thrombocytopenia
• Angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease.
• Congenital or acquired immunodeficiency disorder
• Muscular dystrophy or muscle stiffness
• Non-conscious or voice disorders
• Treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials .
• Participating in another clinical trial within 3 months
• Other serious disease or disorder can seriously affect the ability to participate in research.
• Women who are pregnant or lactating .
• Allergy to antibiotics and anesthetics .
• Do not agree to participate in research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with ADSCs transplantation	Laminectomy	4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
Treatment with ADSCs transplantation	Intradural space	4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
Treatment with ADSCs transplantation	Intrathecal	4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous
Treatment with ADSCs transplantation	Intravenous	4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous

Primary Outcome Measures

Name	Time	Method
Number of Participants with adverse events after transplantation.	24 months	Number of Participants with adverse events is as a measure of safety and tolerability after ADSC transplantation. Adverse events can be impaired liver and kidney, immunosuppression or immune deficiency, hypersensitivity, anaphylactic shock, meningitis symptoms, etc.

Secondary Outcome Measures

Name	Time	Method
Changes of spinal cord edema in the MRI at the lesion site	24 months	Patients take MRI at the lesion site before each injection and after transplantation 6 months, 12 months, 24 months. MRI at the lesion site shows spinal cord edema level is reduced or not.
Urinary and bowel function Improvement	24 months	Bladder pressure monitory to assess ability to feel and control urination and bowel.
Muscle contraction force measurement	24 months	Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.
Significant clinical improvement in ASIA impairment scale and general condition.	24 months	Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.

Trial Locations

Locations (1)

Vietnamese- German Hospital; 🇻🇳 Hanoi, Vietnam