Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.

Biostar Stem Cell Research Institute (R-Bio)

Status and phase

Completed

Phase 1

Conditions

Spinal Cord Injury

Treatments

Other: Autologous Adipose Derived Mesenchymal Stem Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT01274975

Astrostem

Details and patient eligibility

About

This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

Full description

Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

Enrollment

8 patients

Sex

Male

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who understand and sign the consent form for this study.
Age :19-60, males
Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
Duration of injury : > 2 months

Exclusion criteria

Subjects who must put on a respirator
Subjects who had malignant tumor within 5 years
Subjects with a infectious disease include HIV and hepatitis
Subjects who injured brain or spinal cord before spinal cord injury
Subjects who has high body temperature more than 38℃ or acute disorder
Subjects with anemia or thrombocytopenia
Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
Subjects with congenital or acquired immunodeficiency disorders
Subjects with muscular dystrophy or articular rigidity
Patients with clouded consciousness or speech disorder
treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
participating another clinical trials within 3 months
other serious disease or disorder that could seriously affect ability to participate in the study