Stem Cells for Uremic Calciphylaxis Patients

Chronic Kidney Diseases Clinical Trial

Official title:

Effects of Human Amniotic Mesenchymal Stem Cells (hAMSCs) on Wound Healing in Uremic Calciphylaxis Patients: an Open Label Single Arm Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592640
• Other study ID #: Stem cell
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: September 17, 2022

Study information

• Verified date: August 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment for Uremic Calciphylaxis Patients with Human Amniotic Mesenchymal Stem Cells

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 and aggressive treatment of predisposing conditions. Drugs such as sodium thiosulfate, bisphosphonate, 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 uremic calciphylaxis patients with human amniotic mesenchymal stem cells (hAMSCs).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: September 17, 2022
• Est. primary completion date: September 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 18-60 years old.

2. Patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).

3. Clinical diagnosis of calciphylaxis.

4. All subjects signed informed consent.

Exclusion criteria:

1. Patients who refuse to sign informed consent.

2. Patients with malignant tumor or serious mental disease, cardiovascular disease, shock, abnormal liver function and secondary kidney disease.

3. Pregnant or lactating women of childbearing age.

4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.

Related Conditions & MeSH terms

• Calcific Uremic Arteriolopathy
• Calciphylaxis
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Treatment

Intervention

Other:
• Human amniotic mesenchymal stem cells
Intravenous infusion of hAMSCs: once every 3 weeks, a total of 6 times (if cured before the end of the planned course of treatment, it will be terminated in advance). Injection of hAMSCs to local skin lesions: once every 3 weeks, a total of 6 times (if cured before the end of the planned course of treatment, it will be terminated in advance).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Ningning Wang

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

Nigwekar SU, Thadhani R, Brandenburg VM. Calciphylaxis. N Engl J Med. 2018 May 3;378(18):1704-1714. doi: 10.1056/NEJMra1505292. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Torregrosa JV, Sánchez-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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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).	Up to 1 year.
Secondary	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.
Secondary	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.
Secondary	Survival State	Survival time from the hAMSCs treatment started(momths)	From date of treatment until the date of die, assessed up to 1 year.

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