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Trial record 8 of 77 for:    limb ischemia and stem cells

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

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ClinicalTrials.gov Identifier: NCT01663376
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Pusan National University Hospital
Information provided by (Responsible Party):
Biostar

Brief 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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2011

Intervention Details:
  • Procedure: Autologous Adipose Tissue derived MSCs Transplantation
    Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells


Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

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

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes