EUCTR2016-003975-23-ES进行中（未招募）1 期
Efficacy and safety of autologous, mobilized, non-expanded CD133+ cells to treat Asherman´s Syndrome: A prospective, multi-center, phase I/II clinical trial. - ENTIRE
Asherman Therapy S.L.U.0 个研究点目标入组 22 人开始时间: 2018年1月4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
- 22
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
- Female
入选标准
- •1.Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of their illness and voluntarily accepted treatment program, while being fully aware of the potential risks, benefits and any discomfort involved.
- •2.Patients diagnosed with Asherman's Syndrome grade II, III or IV, in accordance with the criteria set forth by the European Society of Hysteroscopy (ESH) or grade II, III, IV or V according to the European Society for Gynaecological Endoscopy (ESGE) classification, who intend to undergo Assisted Reproductive Treatment (ART) with Single Embryo Transfer (SET) of blastocysts (Day 5/6 of development) once cell therapy for endometrial regeneration has been completed. Note: Exceptionally, cases of double embryo transfer (DET) if clinically indicated.
- •3.Patients who, prior to study start, plan to undergo ART in a Hormonal Replecement Therapy (HRT) with donated oocytes (fresh or frozen) or own.
- •- In case of own oocytes at least 2 blastocysts (day 5 or 6 of development) euploid, analyzed by PGD, previously vitrified.
- •- In the case of ovodonation, it may be embryos in the blastocyst stage (fresh or previously vitrified embryos) with or without previous PGD. In the case of vitrified ovodonation embryos it will be necessary to have a minimum of 2 vitrified embryos in the blastocyst stage to meet the inclusion criteria
- •In accordance with standard clinical practice, Pre-implantation Genetic Diagnosis (PGD) is indicated, in compliance with current legislation on human assisted reproductive techniques (Law 14/2006 of May 26). The most common indications for PGD are as follows: Advanced maternal age (age = 36 years), recurring implantation failure, repeated miscarriages or alterations in karyotype of one or both parents as well as any detected in the FISH of sperm cellsor for other reasons that are considered medically indicated.
- •4.Women of child-bearing potential between 18 and 44 years (both included).
- •5.BMI: 18 – 30 Kg/m2 (both included).
- •6.Adequate liver and kidney function, defined as follows: Total bilirubin < 1.5xULN, AST and ALT< 2.5x ULN and
- •Serum creatinine < 1.0 mg/dL; if serum creatinine is > 1.0 mg/dL, then estimated glomerular filtration rate (eGFR) should be > 60 mL/min/1.73 m2.
- •7.Absence of severe heart disease.
- •8.Negative blood pregnancy test.
- •9.ECOG= 0-1.
- •10.Negative HIV, HCV, HbsAg, HBcAg and Syphilis tests (recent, at least 30 days).
- •11.Normal coagulation study.
- •12.Adequate peripheral venous access. Otherwise, the investigator will assess whether central venous catheter should be implanted.
- •13.Absence of severe psychiatric illnesses.
- •14.Patient can adhere to and follow study procedures and checkups, that is, patients who are able to understand and comply with parameters as indicated in the protocol.
- •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 22
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient refuses to receive central venous catheter as proposed by the investigator in cases where there is no peripheral venous access.
- •2.Patients who are allergic to iodine contrast.
- •3.Patients for whom an optimal investigational medicinal product cannot be obtained or infused after performing apheresis and selection. The product is unusable if any of the following mimimun quality criteria are identified:
- •Minimum dose to be perfused lower than 30x106 CD133+. (Note: If the PEI meets the rest of the quality requirements to be perfused, the patient may receive treatment with IGX1 even though the dose is lower than the minimum indicated. The results of this patient will not be included in the Population by protocol, but they can be included for the rest of the population groups).
- •viability lower than 50%.
- •Less than 70% purity.
- •Non-sterile.
- •4.Patients who have participated in another clinical trial or who have received an investigational treatment in the 30 days prior to the study, unless expressly approved by the sponsor.
- •5.Existence of severe or uncontrolled bacterial, fungal or viral infections, which in the opinion of the Principal Investigator may interfere with patient’s participation in the study or with the evaluation of the study results.
- •6.Any illness or medical condition that is unstable or which may put at risk the patient’s safety and her compliance in the study.
研究者
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