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Stem Cells for Uremic Calciphylaxis Patients

Primary Purpose

Chronic Kidney Diseases, Calciphylaxis, Calcific Uremic Arteriolopathy

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Human amniotic mesenchymal stem cells
Sponsored by
Ningning Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Diseases, Calciphylaxis, Calcific Uremic Arteriolopathy, Human Amniotic Mesenchymal Stem Cells, Rare disease (ORPHA280062)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uremic Calciphylaxis Patients

Arm Description

Human amniotic mesenchymal stem cells (hAMSCs)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
Systemic Infection
Assessed by serum hypersensitive C-reactive protein level(hCRP, mg/L). Increased serum hCRP levels above normal ranges indicate infection.
Survival State
Survival time from the hAMSCs treatment started(momths)

Full Information

First Posted
October 3, 2020
Last Updated
August 6, 2022
Sponsor
Ningning Wang
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1. Study Identification

Unique Protocol Identification Number
NCT04592640
Brief Title
Stem Cells for Uremic Calciphylaxis Patients
Official Title
Effects of Human Amniotic Mesenchymal Stem Cells (hAMSCs) on Wound Healing in Uremic Calciphylaxis Patients: an Open Label Single Arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
September 17, 2022 (Anticipated)
Study Completion Date
September 17, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ningning Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment for Uremic Calciphylaxis Patients with Human Amniotic 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Calciphylaxis, Calcific Uremic Arteriolopathy, Treatment
Keywords
Chronic Kidney Diseases, Calciphylaxis, Calcific Uremic Arteriolopathy, Human Amniotic Mesenchymal Stem Cells, Rare disease (ORPHA280062)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uremic Calciphylaxis Patients
Arm Type
Experimental
Arm Description
Human amniotic mesenchymal stem cells (hAMSCs)
Intervention Type
Other
Intervention Name(s)
Human amniotic mesenchymal stem cells
Intervention Description
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).
Primary Outcome Measure Information:
Title
Wound Healing
Description
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).
Time Frame
Up to 1 year.
Secondary Outcome Measure Information:
Title
Wound Pain
Description
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).
Time Frame
Up to 1 year.
Title
Measured Quality of Life
Description
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.
Time Frame
Up to 1 year.
Title
Systemic Infection
Description
Assessed by serum hypersensitive C-reactive protein level(hCRP, mg/L). Increased serum hCRP levels above normal ranges indicate infection.
Time Frame
Up to 1 year.
Title
Survival State
Description
Survival time from the hAMSCs treatment started(momths)
Time Frame
From date of treatment until the date of die, assessed up to 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-60 years old. Patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis). Clinical diagnosis of calciphylaxis. All subjects signed informed consent. Exclusion criteria: Patients who refuse to sign informed consent. Patients with malignant tumor or serious mental disease, cardiovascular disease, shock, abnormal liver function and secondary kidney disease. Pregnant or lactating women of childbearing age. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ningning Wang, Professor
Organizational Affiliation
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiayin Liu, Professor
Organizational Affiliation
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lianju Qin
Organizational Affiliation
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29719190
Citation
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.
Results Reference
background
PubMed Identifier
30304522
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.
Results Reference
background
PubMed Identifier
27712637
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.
Results Reference
background
PubMed Identifier
31681640
Citation
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.
Results Reference
background
PubMed Identifier
28603903
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.
Results Reference
background
PubMed Identifier
30775620
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.
Results Reference
background
PubMed Identifier
24075020
Citation
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 Reference
background
PubMed Identifier
35412950
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/30304522
Description
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URL
http://www.ncbi.nlm.nih.gov/pubmed/27712637
Description
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URL
http://www.ncbi.nlm.nih.gov/pubmed/31681640
Description
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URL
http://www.ncbi.nlm.nih.gov/pubmed/28603903
Description
Related Info
URL
http://www.ncbi.nlm.nih.gov/pubmed/30775620
Description
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URL
http://pubmed.ncbi.nlm.nih.gov/24075020/
Description
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Stem Cells for Uremic Calciphylaxis Patients

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