Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Human amniotic-derived mesenchymal stem cells.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Calciphylaxis, Calcific Uremic Arteriolopathy, Treatment. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study
Overview
Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
Detailed description
Calciphylaxis is a rare, devastating disorder causing excruciatingly painful ischemic skin lesions. Sepsis due to the infection of ulcerated wounds is a common cause of death. To date, practical therapies typically include wound care, pain management, anti-infection, anticoagulant and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate(STS), bisphosphonate, SNF472 and cinacalcet are also suggested. However, it's still a lethal disease with 1-year mortality up to 80% for dialysis patients. Here the investigators plan to treat calciphylaxis patients with human amniotic-derived mesenchymal stem cells (hAMSCs).
Interventions
- Biological Human amniotic-derived mesenchymal stem cells
(1) Intravenous infusion: 1.0×10⁶ cells/kg administered three times consecutively at weeks 1, 2, and 4, followed by once every 4 weeks for a total of 8 doses (6 months). (2) Local injection: 2.0×10⁴ cells/cm² of wound area, administered concurrently. Treatment may be terminated earlier or extended based on clinical condition.
Primary outcome measures
- Wound Healing [Time frame: Up to 1 year.]
Secondary outcome measures (4)
- Wound Pain [Time frame: Up to 1 year.]
- Measured Quality of Life [Time frame: Up to 1 year.]
- Systemic Infection [Time frame: Up to 1 year.]
- Survival State [Time frame: From date of treatment until the date of die, assessed up to 1 year.]
Eligibility criteria
Inclusion criteria
- 18-75 years old.
- Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).
- All subjects signed informed consent.
Exclusion criteria
- Patients who refuse to sign informed consent.
- Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.
- Pregnant or lactating women of childbearing age.
- Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital — Nanjing
Publications
- 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. PMID 29719190
- 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. PMID 30304522
- 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. PMID 27712637
- 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. PMID 31681640
- 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. PMID 28603903
- 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. PMID 30775620
- 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. PMID 24075020
- 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, W PMID 35142858
Identifiers
NCT: NCT04592640 · HOPE-CAMSC