Potential Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

NCT05777213 | Completed Phase 1 DMC

• 1 other identifier: PPZ20192072
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy

Conditions

Trophic Ulcer; Leprosy; Morbus Hansen

Keywords

CM-MSC; Stemcell; trophic ulcer; leprosy; morbus hansen; secretom

Outcome Measures

Primary Outcomes (3)

• Changes in Wound Size - Length

  Digital measurements of Length carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

  4 weeks

• Changes in Wound Size - Width

  Digital measurements of Width carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

  4 weeks

• Changes in Wound Size - Area

  Digital measurements carried out by multiplying the length and width of the wound over time (1 time per week for 4 weeks) in units of cm squares

  4 weeks

Other Outcomes (4)

• Adverse event of Allergic

  4 weeks

• Adverse event of Erythema

  4 weeks

• Adverse event of Angioedema and Urticaria

  4 weeks

Study Arms (1)

Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs)

EXPERIMENTAL

Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) made as much as 0.1cc / 1cm intracutaneously with a flexpen device in the wound area every 2 weeks.

Biological: Secretome

Interventions

Secretome BIOLOGICAL

The interventions given in this study were Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) as much as 0.1cc / 1cm intracutaneously with a flexpen device in the wound area every 2 weeks. The variables in this study were divided into two, namely the independent variable was the use of Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs) were administered intracutaneously, and the dependent variables were wound healing and side effects caused by the interventions given. Wound healing or repair in this study was assessed from several variables, namely the presence of granulation tissue growth, reduced edema, reduced erythema and improvement in wound size both in terms of length, width, and area measured by using a standard ruler and digital photo.

Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic ulcers in Morbus Hansen's patients aged 18-80 years
• Not recovering with routine therapy for at least 1 months
• Trophic ulcers degrees 2 and 3
• Willing to take part in the study
• As well as with the respondent's good health to follow this study.

You may not qualify if:

• Patients who took anticoagulants,
• Patients had hypertension
• Patients had any staging kidney failure
• Patients had a history of blood disorders and pregnancy.

Sponsors & Collaborators

• Yohanes Firmansyah, dr, MH, MM: lead
• Tarumanagara University: collaborator

Study Sites (2)

Sukma Clinic

Tangerang, Banten, 15810, Indonesia

Location

RS Alverno Singkawang

Singkawang, West Borneo, 79123, Indonesia

Location

Related Publications (11)

• Santos VS, Santos LC, Lobo LV, Lemos LM, Gurgel RQ, Cuevas LE. Leprosy and disability in children younger than 15 years in an endemic area of northeast Brazil. Pediatr Infect Dis J. 2015 Mar;34(3):e44-7. doi: 10.1097/INF.0000000000000592.

  PMID: 25389921 RESULT

• Santos VS, de Matos AM, de Oliveira LS, de Lemos LM, Gurgel RQ, Reis FP, Santos VT, Feitosa VL. Clinical variables associated with disability in leprosy cases in northeast Brazil. J Infect Dev Ctries. 2015 Mar 15;9(3):232-8. doi: 10.3855/jidc.5341.

  PMID: 25771459 RESULT

• de Paula HL, de Souza CDF, Silva SR, Martins-Filho PRS, Barreto JG, Gurgel RQ, Cuevas LE, Santos VS. Risk Factors for Physical Disability in Patients With Leprosy: A Systematic Review and Meta-analysis. JAMA Dermatol. 2019 Oct 1;155(10):1120-1128. doi: 10.1001/jamadermatol.2019.1768.

  PMID: 31389998 RESULT

• van Brakel WH, Sihombing B, Djarir H, Beise K, Kusumawardhani L, Yulihane R, Kurniasari I, Kasim M, Kesumaningsih KI, Wilder-Smith A. Disability in people affected by leprosy: the role of impairment, activity, social participation, stigma and discrimination. Glob Health Action. 2012;5. doi: 10.3402/gha.v5i0.18394. Epub 2012 Jul 20.

  PMID: 22826694 RESULT

• Gahalaut P, Pinto J, Pai GS, Kamath J, Joshua TV. A novel treatment for plantar ulcers in leprosy: local superficial flaps. Lepr Rev. 2005 Sep;76(3):220-31.

  PMID: 16248209 RESULT

• Pawitan JA. Prospect of stem cell conditioned medium in regenerative medicine. Biomed Res Int. 2014;2014:965849. doi: 10.1155/2014/965849. Epub 2014 Aug 28.

  PMID: 25530971 RESULT

• Li CY, Wu XY, Tong JB, Yang XX, Zhao JL, Zheng QF, Zhao GB, Ma ZJ. Comparative analysis of human mesenchymal stem cells from bone marrow and adipose tissue under xeno-free conditions for cell therapy. Stem Cell Res Ther. 2015 Apr 13;6(1):55. doi: 10.1186/s13287-015-0066-5.

  PMID: 25884704 RESULT

• Sarasua JG, Lopez SP, Viejo MA, Basterrechea MP, Rodriguez AF, Gutierrez AF, Gala JG, Menendez YM, Augusto DE, Arias AP, Hernandez JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010.

  PMID: 21756569 RESULT

• Vizoso FJ, Eiro N, Cid S, Schneider J, Perez-Fernandez R. Mesenchymal Stem Cell Secretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine. Int J Mol Sci. 2017 Aug 25;18(9):1852. doi: 10.3390/ijms18091852.

  PMID: 28841158 RESULT

• Natallya FR, Herwanto N, Prakoeswa C, Indramaya DM, Rantam FA. Effective Healing of Leprosy Chronic Plantar Ulcers by Application of Human Amniotic Membrane Stem Cell Secretome Gel. Indian J Dermatol. 2019 May-Jun;64(3):250. doi: 10.4103/ijd.IJD_6_17.

  PMID: 31148869 RESULT

• Liew A, O'Brien T. Therapeutic potential for mesenchymal stem cell transplantation in critical limb ischemia. Stem Cell Res Ther. 2012 Jul 30;3(4):28. doi: 10.1186/scrt119.

  PMID: 22846185 RESULT

MeSH Terms

Conditions

Leprosy

Interventions

Secretome

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 21, 2023
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 2, 2023
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

ID (2)