EUCTR2020-002732-75-PL进行中（未招募）1 期
The use of mesenchymal stem cells from the bone marrow stroma for reconstruction of the anterior cruciate ligament - MSC-ACLrep
Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center0 个研究点目标入组 12 人开始时间: 2020年7月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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
- •1. Expressing informed consent to participate in the study along with participation in rehabilitation.
- •2. No contraindications to bone marrow donation.
- •3. Diagnosis of anterior knee cruciate ligament rupture not later than 6 months before qualification.
- •4. Age: 18-45 years old.
- •5. Patient's readiness to follow the procedures related to the trial (in the opinion of the principal investigator).
- •6. For women of childbearing potential, the inclusion criterion is a negative laboratory pregnancy test and no pregnancy during study participation and subsequent imaging (e.g. use of effective contraception and a negative pregnancy test prior to imaging).
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Lack of consent for bone marrow collection or failure to meet the criteria for tissue donation.
- •2. Other ligament pathologies requiring surgery, confirmed by MRI and clinical examination.
- •3. A neurological or psychiatric disorder which, in the investigator's opinion, will prevent sufficient cooperation.
- •4. Failure of at least one organ (heart, liver, kidneys, lungs) with statistically predicted life expectancy <2 years.
- •5. Condition after oncological treatment for malignant tumor (grace period of 5 years).
- •6. Participation in any other clinical trial (grace period of at least six months).
- •7. Participation in a therapeutic experiment (grace period of at least 2 years)
- •8. Allergy to gentamycin or any of the following: penicillin or streptomycin.
- •9. Systemic immunosuppressive treatment currently and / or during the last 3 years before the date of inclusion in the study (non-biological immunosuppressive drugs may be used in doses maintaining remission provided that the exacerbation of the underlying disease is excluded).
- •10. Active infection: HIV, HBV, HCV, syphilis.
- •11. Pregnancy.
- •12. Co-occurrence of another disease at the same time, which in the investigator's opinion may affect the course of the procedures used or the assessment of the safety and effectiveness of the treatment used.
- •13. Irregularities in biochemical tests
- •- hemoglobin <8 g / dl,
- •- Platelet count <80,000 or> 600,000 platelets.
- •14. General diseases, including diabetes, gout, especially those requiring chronic intake of oral steroids, in intravenous or topical injections.
- •15. Osteoarthritis.
- •16. Past infections in the knee.
- •17. Condition after lateral or medial meniscectomy
- •18. Disorder of the mechanical axis of the lower limb> 3 degrees.
- •19. Previous cartilage repair procedures or ligament reconstruction.
- •20. Diseases or injuries of the musculoskeletal system impeding efficient mobility.
- •21. Cardiovascular or neurological diseases affecting the condition of the lower extremities.
- •22. BMI> 27
- •23. Smoking cigarettes, pipes, cigars.
- •24. Alcohol dependence syndrome.
- •25. Use of drugs and / or other intoxicants.
- •26. Contraindications to perform an MRI examination, including all implants for which the patient does not have documentation to determine compatibility with the MRI examination.
研究者
相似试验
进行中（未招募）
1 期
Clinical research using the mesenchymal stem cells from autologous fat tissue of Alzheimer dementiaJPRN-jRCTb050190035OOYAMA TAKAYUKI3
进行中（未招募）
1 期
The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.The study is intended for patients after allogeneic hematopoietic stem cell transplantation (from related and unrelated donors) with steroid-refractory or steroid-dependent GVHD of any type: - Steroid refractory acute GVHD grade II-IV - Steroid refractory chronic GVHD - Steroid-dependent chronic late onset acute GVHD or overlap GVHDEUCTR2013-003626-88-CZFakultní nemocnice Plzen25
已完成
不适用
Bone marrow derived mesenchymal stem cells for the treatment of allograft rejection after renal transplantatioaandoeningen na niertransplantatieallograft rejectionrejection after (renal) transplantation10038430NL-OMON31649eids Universitair Medisch Centrum15
尚未招募
1 期
Transplantation of stem cells for the treatment of type 1 diabetes.Type 1 diabetes mellitus (T1DM).Type 1 diabetes mellitusIRCT20210925052566N1Endocrinology and Metabolism Research Institute30
进行中（未招募）
1 期
Transplantation of Autologous Stem Cells for the treatment of corneal diseasesEUCTR2018-000523-14-ESniversidad Miguel Hernandez30