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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663376
First Posted: August 13, 2012
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pusan National University Hospital
Information provided by (Responsible Party):
Biostar
  Purpose
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

Condition Intervention Phase
Critical Limb Ischemia Procedure: Autologous Adipose Tissue derived MSCs Transplantation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Adipose Tissue Derived Stem Cells Implantation in Patients With Critical Limb Ischemia

Further study details as provided by Biostar:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 20
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663376


Locations
Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Sponsors and Collaborators
Biostar
Pusan National University Hospital
Investigators
Principal Investigator: Han Cheol Lee, M.D. & Ph.D. Pusan National University Hospital
  More Information

Publications:
Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01663376     History of Changes
Other Study ID Numbers: KSC-MSCs-CLI
First Submitted: August 8, 2012
First Posted: August 13, 2012
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Ischemia
Pathologic Processes