Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury. (MSC)
March 24, 2014 updated by: R-Bio
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
safety evaluation
Time Frame: 12weeks
|
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
|
12weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SangHan Kim, MD, Anyang Sam Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 11, 2011
First Posted (Estimate)
January 12, 2011
Study Record Updates
Last Update Posted (Estimate)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 24, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Astrostem
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.