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

NCT ID: NCT02477540

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-06-30

Brief Summary

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

Detailed Description

If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.

A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group).

Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection.

Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.

Conditions

Critical Limb Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2-time injection group : Cellgram-CLI

Within 30 days after extracting bone marrow, autologous bone marrow-derived mesenchymal stem cells is directly injected into the lesion. Then the second cell is injected within 30 days after the first cell injection.

Group Type: EXPERIMENTAL

Cellgram-CLI

Intervention Type: DRUG

Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip

Main ingredient: Autologous bone marrow-derived mesenchymal stem cells

Dosage: 50,000,000 cells/10ml, 2-time injection

Storage: An airtight container, 20~25℃

Injection Method: Intramuscular

Interventions

Cellgram-CLI

Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip

Main ingredient: Autologous bone marrow-derived mesenchymal stem cells

Dosage: 50,000,000 cells/10ml, 2-time injection

Storage: An airtight container, 20~25℃

Injection Method: Intramuscular

Intervention Type: DRUG

Other Intervention Names

Autologous bone marrow derived Mesenchymal Stem Cells

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WoongChol Kang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Other Identifiers

Cellgram-CLI

Identifier Type: -

Identifier Source: org_study_id