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

June 3, 2019 updated by: R-Bio

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Events Analysis (MAEs)
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle-Brachial Index (ABI)
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
48 weeks
Digital subtraction angiography (DSA)
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
48 weeks
Thermography
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
48 weeks
Wong-Baker FACES Pain Rating Score
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
48 weeks
Treadmill test
Time Frame: 48 weeks
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Bio

Collaborators

Pusan National University Hospital

Investigators

  • Principal Investigator: Han Cheol Lee, M.D. & Ph.D., Pusan National University 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.

General Publications

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

January 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSC-MSCs-CLI

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.

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