JPRN-jRCTb041190076已完成2 期
Regenerative medicine using bone marrow-derived mesenchymal cells and platelet-rich plasma for maxillomandibular bone defect - TEOM
Okabe Kazuto0 个研究点目标入组 4 人开始时间: 2019年11月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
We could not enrolled patients with predetermined defect sites, therefore, we could not achieve main purpose of this clinical research. Although it is not possible to fully discuss about the efficacy of this mixture of regenerative cells based on this incompleted study, it seems to be short of number of cells in case of large defect, because no clear improvement in bone regeneration was observed in the BM-MSC group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients who require bone regeneration satisfying all of the inclusion criteria below:
- •more than 20-year-old patients who have a maxillomandibular bone defect that lies over 1/3 of the maxillomandibular area with remaining bone of up to 10 mm in height due to maxillofacial injury or tumor/cyst removal (Patients who had surgical tumor removal in maxillomandibular region must not have relapse/metastasis for 5 year of observation period after the procedure)
- •2. Patients who have received plaque control instructions by a dentist or a dental hygienist and are in a good management of it
- •3. Patients who are willing and able to give signed consent
排除标准
- •1. Patients with bone defect as a result of periodontitis
- •2. Patients for whom surgical procedure is prohibited e.g, severe heart disease, congenital coagulation factor deficiency, leukemia, dialysis, end-stage malignant tumor
- •3. Patients with or with a history of infection
- •4. Patients with diabetes that is not well-controlled
- •5. Patients taking bisphosphonates for more than 3 months or denosumab for more than 6 months before the consent
- •6. Patients with or with a history of malignant tumor
- •7. Patients taking steroids or immunosuppressive drugs who cannot stop such medication for 4 weeks after trial intervention
- •8. Patients in a serious condition of certain diseases
- •9. Patients with difficulty in bone marrow aspiration
- •10. Patients from whom a sufficient amount of blood cannot be taken for PRP preparation
- •11. Patients with contraindications to local anesthetics
- •12. Patients with a history of hypersensitivity to antibiotics, antifungals, thrombin products, or bovine blood-derived products
- •13. Patients taking hemocoagulase products, tranexamic acid products, or aprotinin products
- •14. Female patients who are pregnant, suspected to be pregnant, breastfeeding, or those who do not agree to practice contraception
- •15. Any other patients whom the trial investigator deemed ineligible to this study
研究者
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