A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmicell Co., Ltd.

Criteria

Inclusion Criteria:

• Age from 20 to 80 years

• Patients with resting pain or ulceration of limb (Rutherford's class: II-4, III-5 or III-6)

• Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or TCPO2 ≤ 60mmHg in the foot

• Patients who were unsuitability for percutaneous transluminal angioplasty or a bypass operation

• Patients who are not expected other treatments for at least 6 months

• Patients who can agree to participate in the clinical trial by oneself or by one's legal representative

• Patients who can conduct the clinical trial according to the protocol

Exclusion Criteria:

• Buerger's disease

• History of hematologic disease

• Patients who are at risk of embolism due to atrial fibrillation

• Primary hematologic disease, including hypercoagulable states

• Entrapment syndrome

• Patients with osteomyelitis

• Patients whose blood serum AST(Aspartate transaminase)/ALT(Alanine Transaminase) rates are more than three times the normal maximum rate, or whose creatinine rates are more than 1.5 times the normal maximum rate

• Patients with history of anaphylaxis to gentamicin

• Patients with hypersensitivity of bovine-derived ingredients

• Patients with chronic heart failure, Glomerular disease and Obstructive pulmonary disease

• Patients with Stroke or transient ischemic attack within 6 months prior to registration

• Patients tested positive for HIV(Human Immunodeficiency Virus), HCV(Hepatitis C Virus), HBV(Hepatitis B Virus) and Syphilis

• Patients with history of aorta and artery bypass operation, or angioplasty within 2 months recently

• Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia

• Patients with history of cell therapy

• Type I diabetes

• Uncontrolled diabetes mellitus (HgbA1C>8%)

• Uncontrolled hypertension

• Has a medical record of solid cancer, or diagnosed with solid cancer and currently receiving cancer treatment

• Positive of tumor markers test(AFP((Alpha fetoprotein), CEA(Carcinoembryonic antigen), CA15-3(Cancer antigen 15-3 for breast cancer) and PSA(Prostate-specific antigen), or have received a diagnosis of cancer based on National cancer screening program

• Pregnancy, possible candidate for pregnancy or lactating women

• Infectious disease

• Administrating of immunosuppressive agents, corticosteroid formulation and cell toxicity formulation, or requiring administration of the test period

• Patients already enrolled in another clinical trials or completed within 3 months

• Patients who cannot adapt to the protocol and follow-up observation

• Patients who has experienced drug abuse for the past 1 year

• Patients with any disease or condition which the investigator fell would interfere with trial or the safety of the subject