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

This study has been completed.
Sponsor:
Collaborator:
Pusan National University Hospital
Information provided by (Responsible Party):
K-Stemcell Co Ltd
ClinicalTrials.gov Identifier:
NCT01663376
First received: August 8, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 K-Stemcell Co Ltd:

Primary Outcome Measures:
  • Major Adverse Events Analysis (MAEs) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663376

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

Publications:
Responsible Party: K-Stemcell Co Ltd
ClinicalTrials.gov Identifier: NCT01663376     History of Changes
Other Study ID Numbers: KSC-MSCs-CLI
Study First Received: August 8, 2012
Last Updated: March 24, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014