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

NCT ID: NCT01274975

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-02-28

Brief Summary

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

Detailed 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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Autologous Adipose Derived Mesenchymal Stem Cells

Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells

Intervention Type: OTHER

Other Intervention Names

Astrostem®

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

R-Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SangHan Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Anyang Sam Hospital

References

Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.

Reference Type: RESULT

PMID: 21303266 (View on PubMed)

Other Identifiers

Astrostem

Identifier Type: -

Identifier Source: org_study_id