TRC Autologous Bone Marrow Cells for the Treatment of Appendicular Skeletal Fracture Non-Union
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.
研究概览
简要总结
The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
详细描述
The current standard of care for regeneration of atrophic long bone fracture non-union is autologous bone and marrow chiseled from the patient's iliac crest in open surgery under general anesthesia. This method for harvesting bone and marrow is associated with substantial morbidity of long-term pain, the possibility of deep-seated infection at the site of the bone harvest and other indirect consequences such as extended time of surgery, substantial expense and the potential for blood transfusion. The procedure is also associated with a bone graft failure rate of at least 20%.
Due to the substantial morbidity resulting from the aggressive open surgical procedure, alternatives are sought. Current alternatives to autologous bone include commercially available synthetic, xenograft and allograft matrices, either used alone or combined with bone autograft. Cell-free substitutes, such as matrices combined with platelet rich plasma or recombinant bone morphogenic proteins for osteoinductivity, are also used. These alternatives, although less morbid than a full bone harvest, have not yet been stringently determined to be equivalent. Therefore, there is a continuing search for additional improved alternatives.
Aastrom Biosciences, Inc. has developed a unique process for growing human bone marrow, including the early stem cell populations, from small samples of percutaneously aspirated bone marrow. The process is carried out in the AastromReplicell Cell Production System (ARS).
The study will be performed to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.
The bone marrow cells will be obtained by a brief, percutaneous, small volume aspiration (approximately 30 - 50 ml) from the posterior iliac crest obtained under local and conscious sedation. Percutaneous marrow aspiration is substantially less morbid and time consuming than the current open surgical process of bone autograft harvest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type IIIA or IIIB fracture
- •Fracture gap < 6 cm.
- •Distance of > 4 cm from joint
- •No clinical signs of infection at the wound site or fracture site.
- •Adult patients >18 years of age.
- •Male patients or female patients who are not pregnant or lactating.
- •Patients must have normal organ and marrow function as defined below:
- •Leukocytes >=3000/microliters
- •Absolute neutrophil count >=1500/microliters
- •Platelets >=100,000/microliters
- •AST (SGOT)/ALT (SGPT) <2.5 x institutional limits
- •Creatinine within normal limits or creatinine clearance calculated)>=60 mL/min/1.73 square miter with creatinine above institutional normal.
- •Patients able to give informed consent
排除标准
- •Other long bone fractures, e.g clavicle
- •Patients unable to discontinue ethanol use after surgery including those requiring pharmacologic adjuvant assistance.
- •Although not an exclusion criteria, the attending physician shall discuss with the patient the advantages of discontinuing smoking cigarettes and/or cigars during the term of the study including discontinuing the use of pharmacologic adjuvant assistance such as nicotine suppression.
- •The use or discontinuance of ethanol and/or cigarettes/cigars will be noted in the patient's case report forms.
- •Patients who require corticosteroid anti-inflammatory therapy after surgery.
- •Patients with genetic metabolic bone disease such as hypophosphatasia, or metabolic bone disorders such as primary or secondary hyperparathyroidism caused by chronic renal insufficiency or other disorders.
- •Patients unable to tolerate general anesthesia defined as an ASA criteria of 0 or
- •Patients on systemic antibiotics for suspected wound or fracture site infection.
- •Patients with diabetes.
- •Glasgow score of <
- •Injury severity score of >
- •Allergy to protein products derived from mammalian sources (horse, bovine or porcine) required in the ex-vivo cell production process.
结局指标
主要结局
The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.
次要结局
未报告次要终点