Clinical trial NCT02034669: Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Spinal Cord Injury Treatment
Official title: A Phase II Study of Transplantation of Autologous Adipose Derived Stem Cells (ADSCs) in Completely Acute Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Spinal Cord Injury
Keywords: Acute Spinal cord Injury, Adipose derived stem cells
Lead sponsor: Tri Phuoc Biotechnology., JSC
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with adverse events after transplantation.
timeFrame: 24 months
Secondary outcomes:
measure: Changes of spinal cord edema in the MRI at the lesion site
timeFrame: 24 months
measure: Urinary and bowel function Improvement
timeFrame: 24 months
measure: Muscle contraction force measurement
timeFrame: 24 months
measure: Significant clinical improvement in ASIA impairment scale and general condition.
timeFrame: 24 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnamese- German Hospital
Study officials:
affiliation: Tri Phuoc Biotechnology., JSC
name: Phuc Ba Duong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vietnamese- German Hospital
name: Hoa D Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: