Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- ulcer healing rate
研究概览
简要总结
- Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells
- Bidding Unit: Tenth People's Hospital Affiliated to Tongji University
- Study subjects: diabetic foot patients
- OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy.
- Study Design: Randomized Controlled Clinical Study
- Target number of cases: 60
- Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group.
- Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)
详细描述
research design: A randomized controlled trial was designed. According to the established inclusion criteria/exclusion criteria, the subjects were randomly divided into two groups by random number table. Each group received Mesenchymal Stem Cells(MSCs)from fat sources and conventional diabetic foot treatment according to the estimated results of sample size. A randomized controlled study was conducted with three blinds. The subjects were blind, the interventions were blind, and the evaluators were blind. Subjects were randomly grouped and assisted by coordinators. Follow-up was carried out at 5 time points 7 days, 1, 3, 6 and 12 months after operation to evaluate the pain and functional changes of the subjects, and to evaluate the safety and effectiveness.
Subject inclusion, exclusion criteria and allocation methods entry criteria and exclusion criteria will be executed.
Method of allocation and grouping:
A randomized controlled study was conducted with three blinds. The subjects were blind, the interventions were blind, and the evaluators were blind. Subjects were randomly grouped and assisted by coordinators. After receiving the random number, the test specimens and injections are marked by the research number rather than the names of the subjects. Injections of stem cells or saline are randomly determined by the computer system and will not be disclosed to the subjects. Subject groups would not inform the interveners that each injection was prepared by an assistant and the syringe was covered with black cloth. The operator and the participants would not know which drug was injected. The evaluation is done by a third party and the grouping will not be disclosed to the evaluator.After preliminary screening of qualified subjects, after signing the informed consent and verifying the entry/exclusion criteria by the research unit, and confirming that they meet the selection criteria, according to the results of the random system, the distribution of subjects is strictly carried out according to the random results.Subject Entry Records: Researchers should fill in the corresponding record forms according to the order of participants'enrollment, including the screening form, the identification form and the record form of participants' enrollment. All research-related test sheets need to be attached to the original record sheet kept by the researcher. The original record table is also the original record of this study which is monitored according to Good Clinical Practice(GCP)principle.
Number of cases required:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age ranges from 30 to 65 years. There is no limit for male and female inpatients and outpatients who can be followed up.
- •It conforms to the diagnostic criteria of diabetic foot of the sixth edition of Medical College Textbook Internal Medicine of the Ministry of Health.
- •Severe lower limb ischemia (defined as resting ankle-brachial index (ABI) 0.4-0.8, accompanied by resting pain or intermittent claudication);
- •The expected survival time is longer than one year.
- •No human specific viruses (including HIV, HBV, HCV, HTLV, EBV, CMV, etc.) were detected and screened, and no Treponema pallidum infection was found.
- •Voluntary subjects, the subjects understand the content of the experiment, and voluntarily sign the informed consent before the beginning of the experiment.
排除标准
- •Diabetic retinopathy;
- •There are allergies or contraindications to antiplatelet drugs, anticoagulants, thrombolytics, contrast agents, salicylates, etc.
- •Haemorrhagic tendency, coagulation dysfunction, hypercoagulable constitution or refusal of transfusion therapy exist.
- •In the past five years, patients with malignant diseases or markedly elevated levels of tumor markers in the blood were definitely diagnosed (the estimated survival time was less than 12 months).
- •Pre-acute infectious disease symptoms;
- •Patients with severe liver diseases (such as ascites, esophageal varices, liver transplantation, etc.); hemodynamic instability; renal failure undergoing dialysis; immunosuppressive therapy; decompensated heart failure (New York Heart Association Class III or IV) or myocardial infarction or bypass heart transplantation within three months before the start of the study; Hemorrhagic or ischemic stroke within 3 months before onset;
- •Patients who are still participating in other clinical trials;
- •Other researchers consider that patients who are not eligible for enrollment have other concomitant diseases.
- •Subjects who refused to sign the informed consent or participate in the clinical trial.
- •Immunodeficiency patients;
研究组 & 干预措施
MSCs treatment
On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot
干预措施: MSCs treatment (Biological)
routine treatment
Diabetic foot routine treatment without intervention
结局指标
主要结局
ulcer healing rate
时间窗: up to 4 weeks
Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group
amputation rate
时间窗: up to 4 weeks
Amputation rate = number of amputations / total number of amputations in this group
次要结局
- TcPO2（Transcutaneous oxygen pressure）(2 weeks)
- Wong-Baker Faces Pain Rating Scale(up to 4 weeks)
- ultrasound(2 weeks)
- ABI(ankle brachial index)(2weeks)
- CTA(Computed Tomography angiography)(up to 4 weeks)
- Rutherford Classification(2 weeks)
研究者
Maoquan Li
Prof. Dr. Li
Shanghai 10th People's Hospital