IschemiaPhase 1/2NCT00518934
Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell
A Phase 1/2 study testing Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell in people with Ischemia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Ischemia
- What is being tested?
- Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 Up to 60 years
- All sexes
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Malignant disease
- More than 60 years old
- Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
Dong-Ik Kim, Professor, 82-2-3410-3467, dikim@skku.edu
About this study
The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.
- Conditions
- Ischemia
- Being tested
- Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell
- Keywords
- Safety and efficiency of angiogenesis for patients with limb, ischemia by transplantation of human cord blood mononuclear, cells
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cellOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
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 IschemiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Ik Kim, Professor, Study director, Professor of division of vascular surgery, Samsung Medical Center, Sungkyunkwan University of School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518934
- Sponsor's protocol ID
- 2007-04-064
- Status last verified
- May 2007
- First submitted
- 19 Aug 2007
- Last updated
- 21 Aug 2007
- Results posted
- No
Publications
Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY, Kim NR, Lim JE, Kim AK, Eo HS, Kim BS, Cho SW, Yang SH, Park CJ, Shim JS. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger's disease. Stem Cells. 2006 May;24(5):1194-200. doi: 10.1634/stemcells.2005-0349. Epub 2006 Jan 26.
PubMed 16439614
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Safety and Efficiency of Therapeutic Angiogenesis for Patients With Limb Ischemia by Transplantation of Human Cord Blood Mononuclear Cell
- ClinicalTrials.gov ID
- NCT00518934
- Acronym / sponsor ID
- 2007-04-064
- Conditions
- Ischemia
- Keywords
- Safety and efficiency of angiogenesis for patients with limb, ischemia by transplantation of human cord blood mononuclear, cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- First posted
- 21 Aug 2007 (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.
The purpose of this study is to analyze the safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cells.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Malignant disease
- More than 60 years old
- Other significant medical conditions, including diabetes mellitus, hypertension, hyperlipidemia, etc.
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 |
|---|---|---|
| Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2007.
- Background: PubMed 16439614Kim DI, Kim MJ, Joh JH, Shin SW, Do YS, Moon JY, Kim NR, Lim JE, Kim AK, Eo HS, Kim BS, Cho SW, Yang SH, Park CJ, Shim JS. Angiogenesis facilitated by autologous whole bone marrow stem cell transplantation for Buerger's disease. Stem Cells. 2006 May;24(5):1194-200. doi: 10.1634/stemcells.2005-0349. Epub 2006 Jan 26.
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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.
Dong-Ik Kim, Professor study director
Professor of division of vascular surgery, Samsung Medical Center, Sungkyunkwan University of School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Study for safety and efficiency of therapeutic angiogenesis for patients with limb ischemia by transplantation of human cord blood mononuclear cell in people with Ischemia, run by Samsung Medical Center at 1 site in South Korea.
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 0 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Ik Kim, Professor (82-2-3410-3467, dikim@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518934, 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 21 Aug 2007.