Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

Hadassah Medical Organization1 个研究点分布在 1 个国家开始时间: 2011年9月16日最近更新: 2014年3月4日

适应症

试验速览

阶段: 不适用
发起方: Hadassah Medical Organization
试验地点: 1
主要终点: clinical and radiological bony union at 3 months and 6 months.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .

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

•Ages: 18 to 65
•Males- not involved in active military duty.
•Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
•Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.

排除标准

•Active systemic or local infection.
•History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
•Pathological Fractures.
•Prior Fracture or Prior operation in the current fracture

结局指标

主要结局

clinical and radiological bony union at 3 months and 6 months.

次要结局

未报告次要终点

研究者

发起方

Hadassah Medical Organization

申办方类型

Other

责任方

Sponsor

研究点 (1)

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