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Critical Limb IschemiaNCT01663376

Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Critical Limb Ischemia, run by R-Bio at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Autologous Adipose Tissue derived MSCs Transplantation
How many people
20 participants
Where
1 siteSouth Korea
Study dates
Jan 2009to Apr 2011
Phase
Interventional
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 6 months since the onset CLI(Chronic ASO or Buerger disease)
  • Patients with luminal stenosis > 50% by leg angiography
  • Age is between 20 and 80
  • Patients whose Rutherford's class is II-4, III-5 or III-6 (Patients with rest pain or ischemic ulcer/necrosis)
  • Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization
  • Patients who can give informed consent themselves in writing

Who cannot join

  • Previous or current history of neoplasm or comorbidity that could impact the patient's survival
  • Detection of proximal source of emboli including atrial fibrillation
  • Primary hematologic disease, including hypercoagulable states
  • Detection of proliferative retinopathy
  • Entrapment syndrome
  • Alcohol abuse, cocaine amphetamine etc.
  • Detection of osteomyelitis
  • Uncontrolled DM

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pusan National University Hospital

    Pusan

Other trials in South Korea

About this study

Official title: Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia

Being tested
Autologous Adipose Tissue derived MSCs Transplantation
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Adipose Tissue derived MSCs TransplantationProcedure or surgery

    Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Events Analysis (MAEs)

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs

    Measured: 48 weeks

Secondary outcomes (5)

  1. Ankle-Brachial Index (ABI)

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

    Measured: 48 weeks

  2. Digital subtraction angiography (DSA)

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

    Measured: 48 weeks

  3. Thermography

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

    Measured: 48 weeks

  4. Wong-Baker FACES Pain Rating Score

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

    Measured: 48 weeks

  5. Treadmill test

    To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2012 (estimated)
  2. Study startJan 2009
  3. Primary completionMar 2010
  4. Study completionApr 2011

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01663376
Sponsor's protocol ID
KSC-MSCs-CLI
Status last verified
Jun 2019
First submitted
8 Aug 2012
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.

    PubMed 22498564

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Adipose Tissue derived MSCs Transplantation in people with Critical Limb Ischemia, run by R-Bio 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 6 inclusion and 8 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 5 Jun 2019. 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.

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?

Major Adverse Events Analysis (MAEs) (time frame: 48 weeks). 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 NCT01663376, 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 5 Jun 2019.

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