2024-517011-74-01招募中4 期
Single center, decentralized, parallel group, open, non-randomized, long-term safety follow-up, and exploratory study of long-term effects on inflammatory, immunological, and aging related biomarkers in study participants treated with MSCs.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse Event and Serious Adverse Event rates, including clinically significant laboratory abnormalities.
研究概览
简要总结
To evaluate the long-term safety of treatment with Cellcolabs produced MSCs.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Participants priorly treated with Cellcolabs produced MSCs.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •MSC Treatment Group A Having received treatment with Cellcolabs produced MSCs in any setting, within 12 months of inclusion.
- •Willing and able to comply with the study procedures.
- •Able to read and understand the participant information sheet and informed consent form.
- •Non-treated Control Group B. Matching demographic and anthropometric criteria based on the existing cohort of MSC treated study participants.
- •Willing and able to comply with the study procedures, including blood sampling.
- •Able to read and understand the participant information sheet and informed consent form.
排除标准
- •It is not possible to verify with a reasonable degree of certainty what MSC treatment the participant received prior to joining the study (Group A only).
- •It is not possible to verify with a reasonable degree of certainty that individuals who are volunteering to join the non-treated control group, did not previously receive MSC treatment (Group B only).
- •Group B: Presents with diseases or conditions which are not present in the active treatment group (Group A) and which may impact significantly on the comparability of the groups.
- •Is not suitable for inclusion for any reason as judged by the investigator, i.e., long-term laboratory follow-up procedures not feasible due to old age.
结局指标
主要结局
Adverse Event and Serious Adverse Event rates, including clinically significant laboratory abnormalities.
Adverse Event and Serious Adverse Event rates, including clinically significant laboratory abnormalities.
次要结局
- Change from baseline and after MSC treatment in EQ-5D-5L dimensions
- Change from baseline in laboratory parameters.
研究者
Agnes Le Blanc
Scientific
Cellcolabs AB
研究点 (1)
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