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Completed

NCT Number: NCT01274975

Autologous Adipose Derived MSCs Transplantation in Patient 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.

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Key information

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Adipose Derived Mesenchymal Stem Cells

Other

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

Other names: Astrostem®

Primary outcomes

  1. safety evaluation

    Time frame: 12weeks

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

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Registry information

Official study title

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

Acronym: MSC

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jan 12, 2011
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.