Phase I, Arteriocyte Magellan MAR01 Therapy - Compartment Syndrome and Battlefield Trauma Study Protocol
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Time to treatment failure or death
研究概览
简要总结
Compartment syndrome (CS) is a condition resulting from increased pressure within a compartment, which compromises circulation and can lead to critical limb ischemia. CS is one of the biggest medical challenges that our soldiers face after battlefield related injuries. Chronic or exercise-induced compartment syndrome (CS)rarely requires treatment; acute compartment syndrome is a medical emergency requiring surgery. Treatment of compartment syndrome is limited to fasciotomy, which relieves the pressure.The study purpose is to evaluate the feasibility and safety of the administration of marrow-derived autologous bone marrow concentrate and PRP gel generated by a point of care marrow separation system for the treatment of compartment syndrome. And to show this treatment possibly enhances wound healing, bone healing, perfusion, infection control, and the return of limb function in patients with CS.
Stem Cell and regenerative medicine development efforts for therapeutic angiogenesis and wound healing have predominantly focused on the mechanism of action of a single stem cell population to achieve neovascularization and improve tissue perfusion. It is well documented that other cells, including platelets, are efficient carriers of growth factors (VEGF-PDGF, bFGF, and SDF-1) and play active roles in angiogenesis and wound healing. Arteriocyte's development efforts focus on concentration of autologous bone marrow-derived stem cells and platelets for delivery to the site of injury in a concentration sufficient to effect local tissue revascularization and repair. These products provide for the rapid, bedside preparation of autologous PRP and bone marrow stem cell concentrate.
This clinical trial with the Magellan® System is for the preparation of autologous cell concentrate for the treatment of wound, tissue and bone healing, improved perfusion, infection control, and the return of limb function in patients at risk of amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is able to provide signed, written informed consent prior to study entry
- •Speaks English
- •compartment fasciotomy of tibial compartment
- •Sufficient skin for primary closure
- •Is male or female, 18 - 65 years of age
- •ABI less than 0.7, ankle pressure < 50 mmHg, or toe pressure < 30 mmHg.
- •TcPO2 < 40 mmHg.
- •Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
- •Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry), A partner who is physically unable to impregnate the subject (e.g., vasectomized)Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to patient's cell concentrate administration, Intrauterine device (IUD), or Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
- •If female of childbearing potential, subject must have a negative urine pregnancy test at screening
- •Confirmation of age-appropriate cancer screening consistent with the American Cancer Society guidelines.
排除标准
- •Prior compartment syndrome fracture of same limb
- •Previous fracture of the same limb
- •Any contraindication to stem cell or platelet-rich plasma therapy.
- •Pregnancy
- •Have an active malignancy or have undergone treatment for a malignancy in the preceding 5 years, with the exception of successful treatment of non-melanoma skin cancer.
- •Stage 4 or greater chronic kidney disease (eGFR < 30 ml/min, MDRD estimate).
- •Unwilling or unable to comply with follow-up visits.
- •Is unable to refrain from nicotine, caffeine and alcohol for a period beginning 24 hours prior to the treatment visit
- •Has received an investigational medication or other study trial participation within 30 days prior to the Treatment Visit
- •Non-English Speaker
结局指标
主要结局
Time to treatment failure or death
时间窗: 12 months
* Measurement of rate of infection in the study population * Complications due to wound and/or therapy * Amputation of limb and/or death
次要结局
- Perfusion and quality of life measurements(12 months)