A Label Extension, Single Arm Multicentric Phase III Study to Assess the Efficacy and Safety of Stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Critical Limb Ischemia Due to Atherosclerotic Peripheral Arterial Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 11
- 主要终点
- Evaluation of the efficacy of stempeucel®
研究概览
简要总结
This is a label extension, single arm, multicentric phase III study to assess the efficacy and safety of stempeucel® (adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells) in patients with critical limb ischemia due to atherosclerotic peripheral arterial disease. A total of 24 patients will be enrolled into the study at study centres across India. All patients will be followed up for 1 year after they are enrolled into the study. This is an open label, single arm study group where all the patients will receive stempeucel® (2 million cells per Kg body weight) administered intramuscularly at 40-60 multiple sites to the ischemic limb and also 2 - 3 ml around the ulcer along with standard protocol of care. This study will be conducted to further evaluate the efficacy and safety of the product. The study will be conducted as a clinical trial in accordance to “Guidelines for Stem Cell Research and Therapy†by Department of Biotechnology and ICMR, 2017, the EMA guidelines on human cell based medicinal products, 2007, Schedule-Y and International Council for Harmonisation (ICH) Good Clinical Practices (GCP) and as per the recommendations of the CBBTDEC; approvals will be taken from relevant ethics committees and approval / NOC from DCGI before starting the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females with non-child bearing potential in the age group of 18-70 years of Indian origin.
- •Established CLI, clinically and hemodynamically confirmed as per III-5, or III-6; Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (Patients with wet gangrene must undergo wound debridement / amputation before screening).
- •Patients having Infra-inguinal arterial occlusive disease (as evidenced by MRA) with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
- •Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm square (both inclusive)
- •Ankle Brachial Pressure Index (ABPI) less than or equal to 0.6
- •Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c less than or equal to 8 percentage) without complications
- •Normal liver and renal function
- •On regular medication for hypertension if any
- •Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent including audio – video consent, abide by the study requirements, and agree to return for required follow-up visits.
排除标准
- •Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure
- •Buerger’s Disease as diagnosed by Shionoya criteria
- •Patients with rest pain VAS score less than 3 on rest pain scale of 0 – 10 (0 is no pain; 10 is maximum pain)
- •Ulcers with exposure of tendon and/bone in the shin region.
- •Severe, active infection of the involved extremity, including osteomyelitis, fasciitis, or severe/purulent cellulitis.
- •CLI patient requiring amputation proximal to trans-metatarsal level
- •Type I diabetes
- •Patients having respiratory complications/left ventricular ejection fraction less than 35%
- •Stroke or myocardial infarction within last 3 months
- •Patients with deep vein thrombosis in any limb
- •Patients who are contraindicated for MRA
- •Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- •Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
- •Patients already enrolled in another investigational drug trial or completed within 3 months.
- •Patients who have participated in any stem cell trial / therapy / gene therapy any time in the past
- •Hb percentage less than 10 gm percentage for males, Hb percentage less than 9 gm percentage for females, serum creatinine greater than or equal to 2 mg percentage, serum Total Bilirubin greater than or equal to 2 mg percentage
- •Women with child bearing potential, pregnant and lactating women.
- •Patient with known hypersensitivity to the constituents of the IMP– DMSO
- •Patients tested positive for HIV (1 or 2), HCV, HBV, CMV, TPHA
- •Refusal or inability to give informed consent including audio-video consent.
结局指标
主要结局
Evaluation of the efficacy of stempeucel®
时间窗: 1,3,6,12 months after IMP administration
次要结局
- Assessment of the safety of stempeucel®(Day 7, 1,3,6,12 months after IMP administration)