EUCTR2018-001054-96-CZ进行中（未招募）1 期
Phase IIb, Placebo-Controlled, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Single Implantation in Tibial Fracture - ALLOB-TF2
BioSenic S.A.0 个研究点目标入组 57 人开始时间: 2020年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All patients must satisfy ALL of the following criteria to be included in the study:
- •1. Men and women at least 18 years of age
- •2. Patient diagnosed with a fresh proximal, midshaft or distal tibial fracture with stable definitive reduction and stabilization performed with nail(s) and wound closure (as required) within 14 days of fracture occurrence. This time window of 14 days allows potential intermediate stabilization, wound cleaning and closure.
- •3. Factor(s) at risk of DU/NU:
- •- Mechanism of injury: High energy impact fracture
- •- Any 2 of following patient-related factors: current smoker, chronic NSAID use, high Body Mass Index BMI (>30), polytrauma
- •4. Soft-tissue injury pattern including:
- •- Severe open fracture (Gustilo-Anderson grade IIIa and IIIb)
- •- Open fracture (Gustilo-Anderson grade I-II) with at least one additional risk (current smoker, chronic NSAID use, high BMI (>30), polytrauma, comminuted fracture or cortical continuity = 50%)
- •- closed fracture (Tscherne grade I-III) with at least one additional risk (current smoker, chronic NSAID use, high BMI (>30), polytrauma, comminuted fracture or cortical continuity = 50%)
- •The following fracture patterns are included based on the 2018 AO online classification system:
- •- 41A (Proximal Extraarticular) includes 41A1, 41A2, 41A3
- •- 42A (Simple Diaphyseal) includes 42A1, 42A2, 42A3
- •- 42B (Wedge Fracture) includes 42B2, 42B3 (also called butterfly fracture)
- •- 43A (Distal extra-articular) includes 43A1, 43A2, 43A3 (and all sub-components)
- •- 42C (complex/comminuted): Patients will be included at the discretion of the Medical Monitor.
- •5. Ability to obtain a written, dated, and signed informed consent prior to any study related procedures and ability to understand and comply with study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Current symptoms and/or signs related to the disease under study:
- •1. Definitive reduction at the fracture site under investigation performed with plate, screw, or external fixator (Note: It is acceptable to first stabilize the fracture with an external fixator prior to definitive stabilization with intramedullary nail)
- •2. Patients who did not receive a standard antibiotic prophylaxis before definitive reduction at the fracture site under investigation
- •3. Intra-articular tibial pilon and/or plateau fracture at the site under investigation (i.e., AO classification 41B, 41C, 43B, 43C)
- •4. Known osteomyelitis at the fracture site under investigation
- •5. Residual bone defect post-definitive reduction greater than 1cm at least on 2 cortices at the fracture site under investigation
- •6. Fracture requiring vascular surgery at the site under investigation
- •7. Pathological fractures as judged by the Investigator, such as tumor or metabolic bone disease
- •8. Multi-segmental fracture at the site under investigation (where there are more than 2 separate segments and thus requiring more than a single dose of the investigational product)
- •Current or previous diagnoses, signs and/or symptoms:
- •9. Presence of signs/symptoms suggestive of active systemic infection
- •10. Severe brain trauma with a Glasgow Coma Scale (GCS) [3 – 8] or severe spinal cord injury with impossibility of weight-bearing
- •11. Current or history (within 5 years) of any neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence)
- •12. Known metabolic diseases potentially interfering with bone healing as judged by the Investigator, such as thyroid dysfunction, Paget disease or severe osteoporosis
- •13. Planned or history of solid organ transplantation or bone marrow transplantation
- •14. Known disease, including genetic disease, that may possibly need solid organ transplantation
- •15. Patient with renal impairment requiring dialysis or with clinically significant renal impairment defined as serum creatinine >2.0 x ULN
- •16. Clinically significant hepatic function impairment defined as ALT/AST levels > 3x ULN or total bilirubin levels > 2 x ULN
- •17. Known hematologic disease as evidenced by hematocrit < 25%, white blood cell < 2,500/µl or platelet values < 100,000/µl without another explanation
- •18. Patient with an history of long standing poorly controlled chronic hypertension or diabetes that could put him at risk of needing a kidney transplant later on according to the Investigator
- •19. History of hypersensitivity to human biological material including blood and blood derived products
- •20. Known allergy to DMSO, dextran, gentamicin and any other aminoglycosides
- •Current or previous treatment:
- •21. Participation in another interventional clinical study within 3 months prior to screening
- •22. Any chronic or long term intake of medication within one month that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, teriparatide, systemic steroids, anticoagulant therapies, methotrexate and other immunosuppressant drugs or related immunotherapy
- •23. Previous (within 10 years) treatment with bisphosphonates
- •24. Current treatment with bone morphogenic protein or any other osteo-biologic intervention at the site of the tibial fracture
- •Safety aspects concerning WOCBP: not applicable to Germany
- •25. Actively breast-feeding
- •26. Pregnancy
- •27. Woman with positive u
研究者
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