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CompletedNCT01274975MSCUpdated Mar 26, 2014

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

A Phase 1 interventional study of Autologous Adipose Derived Mesenchymal Stem Cells in Spinal Cord Injury, sponsored by R-Bio. Completed. Open to male participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by R-Bio · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
Male
01

Study summary

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

Read the 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.

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Conditions studied

  • Spinal Cord Injury
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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 8 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

R-Bio is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Interventions

  • OtherAutologous Adipose Derived Mesenchymal Stem Cells

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

    Also known as: Astrostem®

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What researchers measure

Primary outcomes

  1. safety evaluation

    Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected

    Time frame: 12weeks

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 21303266 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01274975
Lead sponsor
R-Bio
Responsible party
Sponsor
First posted
Jan 12, 2011
Start date
Jul 2009
Primary completion
Nov 2009
Completion
Feb 2010
Last update
Mar 26, 2014

Study contacts

SangHan Kim, MD
principal investigator · Anyang Sam Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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