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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:
NCT01274975
First received: January 6, 2011
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
 Other: Autologous Adipose Derived Mesenchymal Stem Cells
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RNL Bio Company Ltd.:

Primary Outcome Measures:
  • safety evaluation [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected


Enrollment: 8
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Autologous Adipose Derived Mesenchymal Stem Cells
    Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
    Other Name: RNL-Astrostem®
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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274975

Sponsors and Collaborators
RNL Bio Company Ltd.
Investigators
Principal Investigator: SangHan Kim, MD Anyang Sam Hospital
  More Information

No publications provided

Responsible Party: RNL Bio Company Ltd.
ClinicalTrials.gov Identifier: NCT01274975     History of Changes
Other Study ID Numbers: RB-Astrostem
Study First Received: January 6, 2011
Last Updated: May 24, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 18, 2012