drugset / Trial / NCT02933827
Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease 2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
Timeline
- Start
- 2018-05-01
- Primary completion
- 2019-04-23
- Completion
- 2023-06-21
Publications
- Lin YC, Hung YP, Tian YC, Wu MJ, Lin HC, Chen SY, Wu MS, Chiou HY. Real-World Data as External Control in Assessing the Efficacy of Allogeneic Adipose-Derived Stem Cells Therapy for Advanced Chronic Kidney Disease. Clin Transl Sci. 2025 Dec;18(12):e70415. doi: 10.1111/cts.70415.
- Zheng CM, Chiu IJ, Chen YW, Hsu YH, Hung LY, Wu MY, Lin YF, Liao CT, Hung YP, Tsai CC, Cherng YG, Wu MS. Allogeneic adipose tissue-derived stem cells ELIXCYTE(R) in chronic kidney disease: A phase I study assessing safety and clinical feasibility. J Cell Mol Med. 2022 May;26(10):2972-2980. doi: 10.1111/jcmm.17310. Epub 2022 Apr 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ELIXCYTE | Cell therapy | 8 ml | Intravenous |
| Subject | ELIXCYTE | Cell therapy | 24 ml | Intravenous |
| Subject | ELIXCYTE | Cell therapy | 40 ml | Intravenous |
| Subject | ELIXCYTE | Cell therapy | 6.4e+07 cells | Intravenous |
| Subject | ELIXCYTE | Cell therapy | 1.92e+08 cells | Intravenous |
| Subject | ELIXCYTE | Cell therapy | 3.2e+08 cells | Intravenous |