2025-520841-60-00招募中3 期
A multi-centre, single-arm study to demonstrate the efficacy of bone marrow allogeneic mesenchymal cells combined with biomaterial (combined ATMP) for bone healing in delayed union and non-union after long bone fractures (OrthoAlloUnion).
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda4 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2025年9月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.
研究概览
简要总结
To determine if the combined treatment of allogeneic hBM-MSCs (ORTHOALLO-BM-MSC) + Biomaterial achieves radiological consolidation in more than 90% of patients at 12 months after surgery for a delayed union or non-union long bone fracture.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old at time of baseline visit
- •Diagnostic of traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with one of those two conditions: a. Delayed union, defined as a fracture with no signs of bone healing, with absence of bone bridging and presence of fracture line after 4 to nine months from the acute fracture. b. Non-union, defined as a fracture not healed that meets the following criteria (Weber 1986), at least 9 months after the originating trauma: 1) Insufficient bone bridging to stabilize the fracture after 9 months since trauma and 2) Insufficient bone biological activity in the fracture and 3) failure of previous treatments.
- •Medical health coverage, including CT at 6- and 12-months post-surgery.
- •Signed informed consent and willingness to comply with the trial visits and procedures.
排除标准
- •Hypertrophic non-unions associated to fracture instability which could be corrected by surgical mechanical stabilization alone (no need of autograft or biological augmentation).
- •Impossibility to meet the appointments for the follow-up visits and imaging.
- •Patients receiving treatment with corticosteroids, immunosuppressive agents, bisphosphonates or denosumab at the time of enrolment.
- •Participation in another clinical investigation that could, in the opinion of the investigator, affect the safety of the participant or the validity of the study results. This includes an investigational drug administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- •Multiple delayed union or non-union long bone fractures that may affect functional recovery and healing of the treated injury.
- •Septic fracture or non-union in an acute, productive stage that requires debridement.
- •Segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc).
- •Any other case that requires a surgical procedure not compliant with the trial.
- •Surgical contraindication of any cause.
- •Pregnant women.
- •Neoplastic disease. Patients considered cancer survivors, carcinoma in situ or basalioma in remission can be included.
- •Included (or expected to be included in a short term) in an organ transplant waiting list.
结局指标
主要结局
Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.
Percentage of patients with radiological consolidation (Yes/No) at 12 months after the intervention.
次要结局
- Percentage of patients with radiological bone consolidation (Yes/No) at 6 months after the intervention.
- Value of Reborne scale at 6 and 12 months
- Pain score at preoperative, 6 and 12 months after surgery, using Numeric Rating Score (NRS) (from 0 to 10) with and without weight bearing.
- Percentage of patients with reoperation at the callus site (Yes/No) at 6 and 12 months after surgical intervention. Estimated as the number of reoperations in the callus site, over the total number of treated patients.
- Percentage of patients with bone consolidation (Yes/No) at 6 and 12 months after the intervention. Estimated as the number of bone consolidations, over the total number of treated patients.
- Volumetric assessment of the regenerated bone, as a percentage of 10cm3 of the affected long bone, applying the Region of Interest methodology using Osirix® software in full CT images, at preoperative, 6 and 12 months after surgery
- Safety endpoints include: - Early complication rate: percentage of patients with complications within the first 3 months after surgery. - Overall complication rate as percentage of patients with local or general complications regarding potential effects of the treatment at any time after surgery.
研究者
Clinical Trial Coordinator
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
研究点 (4)
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