NCT04592640

Brief Summary

Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
29mo left

Started Sep 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Sep 2018Sep 2028

Study Start

First participant enrolled

September 17, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

9 years

First QC Date

October 3, 2020

Last Update Submit

March 2, 2026

Conditions

Calcific Uremic ArteriolopathySafetyEfficacyChronic Kidney DiseasesCalciphylaxisTreatment

Keywords

Chronic Kidney DiseasesCalciphylaxisCalcific Uremic ArteriolopathyHuman Amniotic-derived Mesenchymal Stem CellsRare disease (ORPHA280062)SafetyEfficacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Wound Pain

    Up to 1 year.

  • Measured Quality of Life

    Up to 1 year.

  • Systemic Infection

    Up to 1 year.

  • Survival State

    From date of treatment until the date of die, assessed up to 1 year.

Study Arms (1)

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.

Biological: Human amniotic-derived mesenchymal stem cells

Interventions

Human amniotic-derived mesenchymal stem cellsBIOLOGICAL

(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.

hAMSC Treatment Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (12)

  • 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: 29719190BACKGROUND

  • 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: 30304522BACKGROUND

  • 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: 27712637BACKGROUND

  • 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: 31681640BACKGROUND

  • 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: 28603903BACKGROUND

  • 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: 30775620BACKGROUND

  • 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: 24075020BACKGROUND

  • 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.

    PMID: 35142858RESULT

  • 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.

    PMID: 40518559RESULT

  • 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.

    PMID: 39234636RESULT

  • 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.

    PMID: 40097288RESULT

  • 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.

    PMID: 35412950DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicCalciphylaxisRare Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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

    STUDY DIRECTOR

  • Lianju Qin

    The First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ningning Wang, Professor

CONTACT

86-013813821064wangnn@njmu.edu.cn

Lianju Qin, Professor

CONTACT

86-018012923584ljqin@njmu.edu.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2020

First Posted

October 19, 2020

Study Start

September 17, 2018

Primary Completion (Estimated)

September 17, 2027

Study Completion (Estimated)

September 17, 2028

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)