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

Tri Phuoc Biotechnology., JSC

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Spinal Cord Injury

Treatments: Device: Intradural space; Device: Laminectomy; Device: Intrathecal; Device: Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT02034669

TP-VD-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Treatment with ADSCs transplantation

Experimental group

Description:

4 Intervention: laminectomy, intradural space at damage site, intrathecal at lumbar puncture, intravenous

Treatment:

Device: Intradural space

Device: Laminectomy

Device: Intrathecal

Device: Intravenous

Treatment without ADSCs transplantation

No Intervention group

Description:

Only intervention: laminectomy