drugset / Trial / NCT04592640
Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis
Phase 0
Recruiting
9 enrolled
The First Affiliated Hospital with Nanjing Medical University
Westlake University · collab
NaSingle-groupOpen-labelTreatment
Summary
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Timeline
- Start
- 2018-09-17
- Primary completion
- 2027-09-17
- Completion
- 2028-09-17
Publications
- Background Nigwekar SU, Thadhani R, Brandenburg VM. Calciphylaxis. N Engl J Med. 2018 May 3;378(18):1704-1714. doi: 10.1056/NEJMra1505292. No abstract available.
- Background Seethapathy H, Brandenburg VM, Sinha S, El-Azhary RA, Nigwekar SU. Review: update on the management of calciphylaxis. QJM. 2019 Jan 1;112(1):29-34. doi: 10.1093/qjmed/hcy234.
- Background McCarthy JT, El-Azhary RA, Patzelt MT, Weaver AL, Albright RC, Bridges AD, Claus PL, Davis MD, Dillon JJ, El-Zoghby ZM, Hickson LJ, Kumar R, McBane RD, McCarthy-Fruin KA, McEvoy MT, Pittelkow MR, Wetter DA, Williams AW. Survival, Risk Factors, and Effect of Treatment in 101 Patients With Calciphylaxis. Mayo Clin Proc. 2016 Oct;91(10):1384-1394. doi: 10.1016/j.mayocp.2016.06.025.
- Background Baby D, Upadhyay M, Joseph MD, Asopa SJ, Choudhury BK, Rajguru JP, Gupta S. Calciphylaxis and its diagnosis: A review. J Family Med Prim Care. 2019 Sep 30;8(9):2763-2767. doi: 10.4103/jfmpc.jfmpc_588_19. eCollection 2019 Sep.
- Background Peng T, Zhuo L, Wang Y, Jun M, Li G, Wang L, Hong D. Systematic review of sodium thiosulfate in treating calciphylaxis in chronic kidney disease patients. Nephrology (Carlton). 2018 Jul;23(7):669-675. doi: 10.1111/nep.13081.
- Background Udomkarnjananun S, Kongnatthasate K, Praditpornsilpa K, Eiam-Ong S, Jaber BL, Susantitaphong P. Treatment of Calciphylaxis in CKD: A Systematic Review and Meta-analysis. Kidney Int Rep. 2018 Oct 9;4(2):231-244. doi: 10.1016/j.ekir.2018.10.002. eCollection 2019 Feb.
- Background Torregrosa JV, Sanchez-Escuredo A, Barros X, Blasco M, Campistol JM. Clinical management of calcific uremic arteriolopathy before and after therapeutic inclusion of bisphosphonates. Clin Nephrol. 2015 Apr;83(4):231-4. doi: 10.5414/CN107923.
- Results Qin L, Zhang J, Xiao Y, Liu K, Cui Y, Xu F, Ren W, Yuan Y, Jiang C, Ning S, Ye X, Zeng M, Qian H, Bian A, Li F, Yang G, Tang S, Zhang Z, Dai J, Guo J, Wang Q, Sun B, Ge Y, Ouyang C, Xu X, Wang J, Huang Y, Cui H, Zhou J, Wang M, Su Z, Lu Y, Wu D, Shi J, Liu W, Dong L, Pan Y, Zhao B, Cui Y, Gao X, Gao Z, Ma X, Chen A, Wang J, Cao M, Cui Q, Chen L, Chen F, Yu Y, Ji Q, Zhang Z, Gu M, Zhuang X, Lv X, Wang H, Pan Y, Wang L, Xu X, Zhao J, Wang X, Liu C, Liang N, Xing C, Liu J, Wang N. A novel long-term intravenous combined with local treatment with human amnion-derived mesenchymal stem cells for a multidisciplinary rescued uremic calciphylaxis patient and the underlying mechanism. J Mol Cell Biol. 2022 Jun 17;14(2):mjac010. doi: 10.1093/jmcb/mjac010.
- Results Lu S, Zeng M, Li F, Ouyang C, Wu J, Hu J, Yuan Y, Cui H, Xu Y, Liu W, Zhang L, Lu Y, Su Z, Ye X, Li C, Bian A, Jiang C, Cui Y, Ma X, Ning S, Lv X, Wang L, Yang J, Wang X, Liang N, Xing C, Liu J, Qin L, Wang N. Treatment effects of human amnion-derived mesenchymal stem cells for skin lesions and metastatic pulmonary calcification in calciphylaxis patients - case series and literature review. Ren Fail. 2025 Dec;47(1):2516207. doi: 10.1080/0886022X.2025.2516207. Epub 2025 Jun 15.
- Results Wang N, Angioi A, Hanset N, Ye X, Lu S, Zhu Y. Individualizing the lifesaving journey for calciphylaxis: addressing rapidly progressive attacks with multidimensional and AI research for regenerative medicine. Ren Fail. 2024 Dec;46(2):2392846. doi: 10.1080/0886022X.2024.2392846. Epub 2024 Sep 5. No abstract available.
- Results Wu D, Lu S, Hu J, Zeng M, Wu J, Li C, Tang X, Lu T, Zhu Y, Liu J, Qin L, Wang N. Calciphylaxis: ongoing challenges and treatment opportunities with mesenchymal stem cells. J Mol Cell Biol. 2025 Jul 28;17(2):mjaf009. doi: 10.1093/jmcb/mjaf009.
- Naeem A, Gupta N, Naeem U, Khan MJ, Elrayess MA, Cui W, Albanese C. A comparison of isolation and culture protocols for human amniotic mesenchymal stem cells. Cell Cycle. 2022 Aug;21(15):1543-1556. doi: 10.1080/15384101.2022.2060641. Epub 2022 Apr 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Human amniotic-derived mesenchymal stem cells | Cell therapy | 20000 unknown | Intravenous |
| Subject | Human amniotic-derived mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intravenous |