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| Name | Class |
|---|---|
| Westlake University | OTHER |
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Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hAMSC Treatment Group | Experimental | hAMSC treatment regimen: (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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human amniotic-derived mesenchymal stem cells | Biological | (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below: (1)Size; (2)Depth; (3)Edges; (4)Undermining or pockets; (5)Necrotic tissue type; (6)Necrotic tissue amount; (7)Exudate type; (8)Exudate amount; (9)Surrounding skin color; (10)Peripheral tissue edema; (11)Peripheral tissue induration; (12)Granulation tissue; (13)Epithelialization. Each item was rated on a scale of 1 (best) to 5 (worst). The BWAT total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst). | Up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Pain | Assessed by pain visual analog scale (VAS). VAS Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. VAS Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. VAS Score range 0 (best) to 100 (Worst). |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningning Wang, Professor | Contact | 86-013813821064 | +8613813821064 | wangnn@njmu.edu.cn |
| Lianju Qin, Professor | Contact | 86-018012923584 | ljqin@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ningning Wang, Professor | The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital | Principal Investigator |
| Jiayin Liu, Professor | The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29719190 | 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. | |
| 30304522 | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002115 | Calciphylaxis |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Up to 1 year. |
| Measured Quality of Life | The wound-quality of life(QoL) questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from "not at all" to "very much". The total score is the average of the 17 responses. | Up to 1 year. |
| Systemic Infection | Assessed by serum hypersensitive C-reactive protein level(hCRP, mg/L). Increased serum hCRP levels above normal ranges indicate infection. | Up to 1 year. |
| Survival State | Survival time from the hAMSCs treatment started(momths) | From date of treatment until the date of die, assessed up to 1 year. |
| Lianju Qin | The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital | Principal Investigator |
| 27712637 | 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. |
| 31681640 | 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. |
| 28603903 | 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. |
| 30775620 | 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. |
| 24075020 | 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. |
| 35142858 | Result | 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. |
| 40518559 | Result | 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. |
| 39234636 | Result | 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. |
| 40097288 | Result | 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. |
| 35412950 | Derived | 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. |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |