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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274975
First Posted: January 12, 2011
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biostar
January 6, 2011
January 12, 2011
March 26, 2014
July 2009
November 2009   (Final data collection date for primary outcome measure)
safety evaluation [ Time Frame: 12weeks ]
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
Same as current
Complete list of historical versions of study NCT01274975 on ClinicalTrials.gov Archive Site
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Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injury
Other: Autologous Adipose Derived Mesenchymal Stem Cells
Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
Other Name: Astrostem®
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2010
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
19 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01274975
Astrostem
Not Provided
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Biostar
Biostar
Not Provided
Principal Investigator: SangHan Kim, MD Anyang Sam Hospital
Biostar
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP