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

Acute Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02034669
• Other study ID #: TP-VD-2012
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 6, 2014
• Last updated: January 10, 2014
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2014
• Source: Tri Phuoc Biotechnology., JSC
• Contact: Phuc Ba Duong, MD
• Phone: +17143607716
• Email: triphuocbio[@]gmail.com
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• Laminectomy
surgical laminectomy with glial scar resection
• Intradural space
ADSCs injection into Intradural space at damage site
• Intrathecal
ADSCs Intrathecal into lumbar puncture
• Intravenous
ADSCs intravenous

Locations

Country	Name	City	State
Vietnam	Vietnamese- German Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Tri Phuoc Biotechnology., JSC

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with adverse events after transplantation.	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.	24 months	Yes
Secondary	Changes of spinal cord edema in the MRI at the lesion site	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.	24 months	Yes
Secondary	Urinary and bowel function Improvement	Bladder pressure monitory to assess ability to feel and control urination and bowel.	24 months	Yes
Secondary	Muscle contraction force measurement	Comparison the electromyography (EMG) score during contraction of given muscles before each injection and after transplantation 6 months, 12 months and 24 months.	24 months	Yes
Secondary	Significant clinical improvement in ASIA impairment scale and general condition.	Patients are assess improvement level based on American Spinal Injury Assessment scale of A,B,C,D or E before and after transplantation.	24 months	Yes