DRKS00030630招募中不适用
Integrated healthcare of new therapies through telemedicine, empowerment, gene therapeutics, registry establishment, drug safety, therapy pathways and reimbursement - INTEGRATE-ATMP
niversitätsklinikum Heidelberg, Klinik für Hämatologie, Onkologie und Rheumatologie Innere Medizin V0 个研究点目标入组 650 人开始时间: 2023年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 one（—）
- 性别
- All
入选标准
- •Participating patients must be insured with a statutory health insurance
- •- Signed treatment contract between practitioner and patient/parents according to §630a BGB
- •- Treatment in one of the participating treatment centers
- •- Age of CAR-T-cell therapy patients: = 18 years
- •- Age of patients for SMA, ADA-SCID and MLD: ? 7 years
- •- Ability to understand the patient's information and sign the consent form
- •- Ability to consent by patients themselves or by parents
- •- Consent to the exchange of data between practitioners, the telemedicine platform and the INTEGRATE register
- •- Indication for ATMP treatment within the existing marketing authorisation for one of the following indications prior to inclusion:
- •o CAR-T cell therapy: patients with diseases of the lymphatic system and planned commercial CAR-T cell therapy in an approved indication
- •o Spinal muscular atrophy (SMA): patients with SMA and planned commercial gene therapy with onasemnogen abeparvovec in the approved indication
- •o Severe combined immunodeficiency in adenosine desaminase deficiency (ADA-SCID): patients with ADA-SCID and planned gene therapy with autologous CD34+ cells transduced to express adenosine desaminase (ADA) in the approved indication.
- •o Metachromatic leukodystrophy (MLD): patients with MLD and planned gene therapy in the approved indication (Atidarsagen Autotemcel – autologous lentiviral transduced CD34+ cells to replace the arylsulfatase A gene).
排除标准
- •- ATMP patients without a statutory health insurance
- •- Treatment with ATMP as part of a clinical trial or off-label use
- •- patients that are not able to give informed consent
- •- Project content is not comprehensible to patients
研究者
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