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

Spinal Cord Injury Clinical Trial

— MSC  

Official title:

Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274975
• Other study ID #: Astrostem
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2011
• Last updated: March 24, 2014
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: March 2014
• Source: Biostar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biostar

References & Publications (1)

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/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety evaluation	Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected	12weeks	Yes