Clinical trial NCT02477540: A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
Official title: An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Critical Limb Ischemia
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Ankle Brachial Pressure Index, ABPI
timeFrame: 6 months after BM-MSC therapy
Secondary outcomes:
measure: Collateral vessel formation on digital subtraction angiography (DSA)
timeFrame: 6 months after BM-MSC therapy
measure: Difference of Wound size
timeFrame: 6 months after BM-MSC therapy
measure: Improved transcutaneous oxygen pressure (TCPO2)
timeFrame: 6 months after BM-MSC therapy
measure: Pain on the Visual Analogue Scale(VAS)
timeFrame: 6 months after BM-MSC therapy
measure: Reduced limb amputation
timeFrame: 6 months after BM-MSC therapy
measure: Temperature change on thermography
timeFrame: 6 months after BM-MSC therapy
measure: Dose about using analgesic medicine
timeFrame: 6 months after BM-MSC therapy
measure: Change in Rutherford classification
timeFrame: 6 months after BM-MSC therapy
measure: Frequency about using analgesic medicine
timeFrame: 6 months after BM-MSC therapy
Other outcomes:
measure: For safety analysis we will observed clinical laboratory tests, physical examinations, tumor marker tests
timeFrame: 12 months after BM-MSC therapy
measure: occurrence and severity of adverse events
timeFrame: 12 months after BM-MSC therapy
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: WoongChol Kang, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: