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Completed

NCT Number: NCT01663376

Safety and Effect of Adipose Tissue Derived Mesenchymal 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

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital

Pusan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Adipose Tissue derived MSCs Transplantation

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

R-Bio

Industry

Collaborators

  • Pusan National University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 13, 2012
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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