CTRI/2019/12/022351已完成3 期
A Label extension, Randomized, Double Blind, Placebo Controlled, Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of Peri-ulcer Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Non-Healing Diabetic Foot Ulcer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 22
- 主要终点
- 1. Proportion of patients with complete healing/closure of the target ulcer at any time during the 12 week period with sustained complete closure for 12 additional weeks of follow-up
研究概览
简要总结
| This study is a Randomized, Double Blind, Placebo Controlled, Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of Peri-ulcer Administration of stempeucel® in Patients with Non-Healing Diabetic Foot Ulcer that will be conducted in twenty two (22) centers in India. |
The primary objective will be to evaluate the efficacy of periulcer administration of stempeucel® in healing of DFU.
The secondary objective will be to assess the safety of periulcer administration of stempeucel® in DFU
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must satisfy all of the following criteria to be included in the study:
- •A signed and dated informed consent form and audio- visual consent has been obtained from the patient
- •Patient is able and willing to comply with study procedures
- •Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-70 years
- •Patient has type 2 diabetes mellitus
- •HbA1c, less than or equal to 10%
- •Presence of single non-healing DFU in the target limb that meets all of the following criteria: a) Ulcer in the plantar surface of the foot b) Ulcer has been diagnosed as a full-thickness DFU c) Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement at the time of screening) d) Wagner grade 1 at initialization of the clinical trial (ulcer should not have evidence of exposed muscle, tendon, bone or joint capsule) e) Non healing study ulcer for the duration of at least 4 weeks at the time of the screening visit (to be confirmed by the investigator during interviewing the patient- documented evidence in the form of hospital records / prescription from the doctor is required)
- •Patient has adequate vascular perfusion of the affected limb, as defined by Ankle-Brachial Index (ABI) ≥ 0.7 and < 1.
- •If ABI is >1.3 then Toe Brachial Index (TBI) will be performed and TBI should be ≥ 0.5
- •Patient or responsible caregiver is willing and able to maintain the required off-loading (as applicable for the location of the ulcer) and applicable dressing changes INCLUSION CRITERIA AT RANDOMIZATION
- •Presence of single non-healing DFU in the target limb that meets all of the following criteria: a) Ulcer in the plantar surface of the foot b) Ulcer has been diagnosed as a full-thickness DFU c) Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement if clinically indicated at the time of randomization) d) Wagner grade 1 at initialization of the clinical trial (ulcer should not have evidence of exposed muscle, tendon, bone or joint capsule) e) Ulcer which is non infected.
排除标准
- •Patients may not be selected if any of the following criteria are present
- •Patients with type I diabetes mellitus
- •Patients with 2 or more ulcers in the target limb
- •Patient with known hypersensitivity to the constituents of the IMP – DMSO, Dextran 40, CryoStor®.
- •Pregnant and lactating women
- •Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial any time in the past
- •Patient has a current or past history of any cancer
- •Patients currently undergoing dialysis (within 30 days of screening)
- •Patient is currently receiving (i.e., within 30 days of screening) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with or affect the rate and quality of wound healing (e.g., systemic steroids, anticoagulants, immunosuppressive therapy, autoimmune disease therapy, revascularization procedure in the target limb, angioplasty in the target limb or radiation therapy in the target limb).
- •Patients who have undergone thrombolysis within 30 days of screening
- •Patients with BMI > 32.5 kg/m2
- •Patients with serum albumin < 3 gm %
- •Patients with Hb < 9 gm %
- •Patients serum bilirubin level 2 times more than upper normal limit
- •Patient has any of the following unstable conditions or circumstances that could interfere with the standard care of treatment: a) Inability to comply with treatment visit schedule b) Mental incapacity c) Current substance abuse
- •Patient has a history of or any of the following current illnesses or conditions (other than diabetes) which in the opinion of investigator, would compromise the safety of the patient, or the normal wound healing process: a) End-stage renal disease (CKD stage IV or V) (patients with serum creatinine > 3 mg/dl) b) Severe malnutrition c) Liver disease (patients bilirubin 2 times more than upper normal limit) d) Aplastic anemia e) Scleroderma f) Connective tissue disorder g) Exacerbation of sickle cell anemia h) Disabling cardiac disease i) Disabling pulmonary disease j) Excessive lymphedema k) Unstable Charcot foot or Charcot with bony prominence
- •Positive for HIV, HCV, HBV, VDRL
- •Patient has ulcers secondary to a disease other than diabetes, e.g., vasculitis, or hematological disorders
- •Patient has clinical and radiographic (X-ray) evidence of osteomyelitis with necrotic soft bone in the target limb
- •Patient with Chopart amputation in the target limb
- •Patient has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of screening
- •Patient has been treated with hyperbaric oxygen within 5 days of screening.
- •Patient has suspected or confirmed signs/symptoms of gangrene or acute wound infection or cellulitis on any part of the affected limb. (Patients with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection; the affected limb should be clinically free of infection).
- •Patients who 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
- •Patient is an employee or blood relative of any member of the Investigational site or the Sponsor EXCLUSION CRITERIA AT RANDOMIZATION
- •Reduction in the ulcer area by more than or equal to 30% (post debridement if clinically indicated and performed)compared to the measurement at screening visit (post debridement) ELIGIBILITY CRITERIA BEFORE IMP ADMINISTRATION
- •Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement if clinically indicated)
- •Ulcer which is non infected.
结局指标
主要结局
1. Proportion of patients with complete healing/closure of the target ulcer at any time during the 12 week period with sustained complete closure for 12 additional weeks of follow-up
时间窗: 1. 24 weeks | 2. 24 weeks
2. Rate of reduction in size of the target ulcer during the 24 weeks of follow-up
时间窗: 1. 24 weeks | 2. 24 weeks
次要结局
- Time to complete closure of target ulcer(24 Weeks)
- Proportion of patients with at least 50% closure of target ulcer during the 24 week period(24 Weeks)
- Proportion of patients with complete healing/closure of the target ulcer at any time during the 24 week follow-up period(24 Weeks)
- Safety endpoints:(1.The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).)
- 2. Assessment of clinical laboratory and ECG parameters(After the treatment)
- 3. Physical examination findings and assessment of vital signs(After the treatment)
研究者
研究点 (22)
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