Spinal Cord InjuryPhase 1MSCNCT01274975
Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
A Phase 1 study testing Autologous Adipose Derived Mesenchymal Stem Cells in people with Spinal Cord Injury, run by R-Bio.
Trial summary
This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Autologous Adipose Derived Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: 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.
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Autologous Adipose Derived Mesenchymal Stem Cells
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Derived Mesenchymal Stem CellsOther
Also called Astrostem®
Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
What is being measured
The primary outcome is the main question the study is designed to answer.
safety evaluation
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SangHan Kim, MD, Principal investigator, Anyang Sam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274975
- Sponsor's protocol ID
- Astrostem
- Acronym
- MSC
- Status last verified
- Mar 2014
- First submitted
- 6 Jan 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01274975
- Acronym / sponsor ID
- MSC / Astrostem
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Adipose Derived Mesenchymal Stem CellsAlso: Astrostem®Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells | Other | – |
Primary outcome
safety evaluation
Time frame: 12weeks
Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Results publication: PubMed 21303266Ra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangHan Kim, MD principal investigator
Anyang Sam Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Adipose Derived Mesenchymal Stem Cells in people with Spinal Cord Injury, run by R-Bio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety evaluation (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.