EUCTR2006-005159-14-IT进行中（未招募）不适用
: A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx, Umbilical Cord Blood (UCB) Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies following Myeloablative Therapy - ExCE
GamidaCell-Teva Joint Venture Ltd.0 个研究点目标入组 100 人开始时间: 2008年8月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •a.Subject is a candidate for allogeneic SCT for treatment of one of the following hematologic malignancies.b.Age >12 and <55.
- •c.Availability of CBU that meets the following requirements:
- •c.1.Matched at 4, 5, 6/6 HLA class I and II (high resolution).
- •c.2.The CBU will have undergone volume reduction prior to cryopreservation and will have been preserved in two fractions, of which the larger (or equal) fraction contains a minimum of 1.0x107 TNC/kg (pre-thaw).
- •c.3.CBUs should be obtained from public CBBs where they are tested for infectious agents in compliance with the applicable local requirements and regulations.
- •d.Patients? Performance score ≥70% by Karnofsky (age ≥13) or a Lansky Play-Performance scale of ≥70% (age < 13).
- •e.Patient has sufficient physiologic reserves including:
- •e.1.Left ventricular ejection fraction ≥40%.
- •e.2.Pulmonary function test demonstrating a corrected CO2 diffusion capacity ≥50% predicted.
- •e.3.Serum Creatinine <1.6 mg/dl.
- •e.4.Serum Bilirubin < 2.0 x upper limit of normal range.
- •e.5.SGPT (ALT) ≤ 2.0 x upper limit of normal range.
- •f.Patient must have at least one of the following back-up stem cell sources in case of engraftment failure:
- •f.1.Patient is willing to undergo BM harvest or peripheral blood progenitor cells (PBPC) collection for use in case of engraftment failure (for HD or NHL patients only).
- •f.2.Patient has a second CBU as a possible back up.
- •f.3.Patient?s haploidentical family member has been identified and agreed (by signing a written informed consent) to donate hematopoietic stem cells in case of engraftment failure.
- •g.Patient or guardian signs the written informed consent after being aware of the nature of the patients? disease and willingly consents to the treatment program after being informed of alternative treatments, potential risks, benefits, and discomforts
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a.Less than twenty-one days have elapsed since the patient's last radiation or chemotherapy prior to screening (except Hydroxyurea).
- •b.HIV positive.
- •c.Pregnancy or lactation.
- •d.Uncontrolled bacterial, fungal or viral infection.
- •e.Patients with signs and symptoms of active central nervous system (CNS) disease.
- •f.Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens.
- •g.Prior allogeneic cell transplant.
- •h.Allergy to bovine or to any product, which may interfere with the treatment.
- •i.Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor.
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