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IRCT20211021052828N2 IRCT 2022-05-15 Rasht University of Medical Sciences Safety and efficacy of umbilical cord-derived mesenchymal stem cells treatment for patients with Critical Limb Ischemia Evaluation the safety of umbilical cord-derived mesenchymal stem cells transplantation in the patients with critical limb ischemia (Phase I clinical trial) 2022-05-14 anticipated 5 Complete https://irct.ir/trial/62844 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Critical Limb Ischemia. Intervention group: This study is defined in phase I of the clinical trial, so there is no control group and a treatment group with 5 patients will be examined for safety (Safty) with a minimum dose of therapy.. Yes - There is a plan to make this available What will be shared: Some portion of the data, such as information about the main outcome can be shared. When: Two years To whom: physician and the treatment staff Conditions: Physicians to investigate and improve the treatment Where to obtain: Elham vojoudi How to obtain: By email and necessary tasks and administrative procedures Comments:
public Elham Vojoudi
Razi University Hospital, Sardare Jangal Blvd, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3354 2460 elhamvojoodi@yahoo.com Rasht University of Medical Sciences scientific Elham Vojoudi
Razi University Hospital, Sardare Jangal Blvd, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3354 2460 elhamvojoodi@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Aged 18–60 years patients with Type I or II diabetes, established more than one year ago Glycosylated hemoglobin (HbA1c) < 8% Patients suffering from infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) Subjects with poor or norevascularization option (surgical or endovascular) classified as CLI Rutherford Category III-5 or Patients in Rutherford- III-6 as the gangrene extends maximally up to the metatarsal head but limited to toes (Patients with wet gangrene must undergo wound debridement/amputation before screening). For these patients, one of the following options must be confirmed and documented at screening: Ankle systolic pressure < 70 mmHg, systolic toe pressure < 50 mmHg, poor or no revascularization option, since the revascularization using surgical or endovascular methods are not feasible in the investigator opinion due to the anatomy of existing vessels and/or existing comorbidity and/or previously failed surgical or endovascular revascularization. 18 years 60 years Both Advanced CLI with major tissue loss due to the significant ulceration/gangrene proximal to the metatarsal heads (CLI Rutherford Category 6). Significant ulceration/gangrene means any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads CLI Rutherford Category 4 Subjects with arterial insufficiency in the lower limb as a result of acute limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger's Disease), systemic sclerosis (both limited and diffuse forms)) Clinical evidences of invasive infection on the targeted leg with the major tissue loss in the mid-foot or heel involving tendon and/or bone, and/or when intravenous antibiotics are required to treat the infection according to the Investigator At screening, the presence of only neuropathic ulcers on the targeted leg Amputation at the talus or above parts of the targeted leg major amputation within the first month after randomization Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure platelet count < 50,000/μL International normalized ratio (INR) > 1.5 for patients on anticoagulant medication .INR > 1.5 is allowed when the Investigator and the haematologist consider the patient eligiblity for BM collection. Evidence of moderate to severe hepatocellular dysfunction according to the physician Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months. For example: a. Concurrent severe congestive heart failure (New York Heart Association Classes III and IV). b. Patients with the left ventricular ejection fraction < 35%. c. Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within four weeks before screening. d. Coronary artery bypass grafting or percutaneous coronary intervention within one month before screening. e. A renal and/or carotid revascularization procedure within one month of screening. f. Transient ischemic attack within three months prior to screening. g. Deep vein thrombosis within three months prior to screening. h. Subjects with immunocompromised conditions, organ transplant recipients and/or subjects in need of immunosuppressive therapy. i. neurodegenerative disease such as Alzheimer disease Subjects who participate in another clinical interventional trial Patients who are contraindicated for MRA Patients with deep vein thrombosis in any limb Documented terminal illness or cancer or any concomitant disease process with a life expectancy of <1 year History of severe alcohol or drug abuse within 3 months of screening Hb < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, Total serum Bilirubin ≥2mg% Pregnant and lactating women G173.9 Critical Limb Ischemia Treatment - Other Intervention group: This study is defined in phase I of the clinical trial, so there is no control group and a treatment group with 5 patients will be examined for safety (Safty) with a minimum dose of therapy. Wound healing extent. Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: Square centimeters. Temperature changes. Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: Thermography. Peripheral pulses. Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: Palpation. Pain on the Visual Analogue Scale (VAS). Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: Examination. Ankle–brachial index. Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: The ABI is performed by measuring the systolic blood pressure from both brachial arteries and from both the dorsalis pedis and posterior tibial arteries after the patient has been at rest in the supine position for 10 minutes. Reduced limb amputation. Timepoint: 1, 2, 3 months after implantation of stem cells. Method of measurement: Observation. Collateral blood vessels angiogenesis. Timepoint: One, 2, 3 months after implantation of stem cells. Method of measurement: Magnetic resonance angiogram (MRA). CT Angiography. Timepoint: Before intervention and 1, 2, 3 months after implantation of stem cells. Method of measurement: X-Ray. Sinacell Research and Production Co. Rasht University of Medical Sciences Sinacell Research and Production Co. Approved 2022-04-05 Ethics committee of Guilan university of medical sciences Sardare Jangal Blvd Rasht Guilan Iran (Islamic Republic of)