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

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

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

Study Overview

• Status: Completed
• Conditions: CM-MSC ; Stem Cell ; Trophic Ulcer ; Leprosy ; Morbun Hansen; Secretom
• Intervention / Treatment: Biological: Secretome

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Banten
    • Tangerang, Banten, Indonesia, 15810
      • Sukma Clinic
  • West Borneo
    • Singkawang, West Borneo, Indonesia, 79123
      • RS Alverno Singkawang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event of Allergic	Assessment of side effects in the form of allergies for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and sought to know about the causal from these side effects	4 weeks
Adverse event of Erythema	Assessment of side effects in the form of erythema for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects	4 weeks
Adverse event of Angioedema and Urticaria	Assessment of side effects in the form of Angioedema and Urticaria for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects	4 weeks
Adverse event of Tumor	Assessment of side effects in the form of Tumor for 4 weeks the intervention is expressed in the form of incidence with consideration of diagnosis by a doctor and searched for causal from these side effects	4 weeks

Collaborators and Investigators

• Sponsor: Yohanes Firmansyah, dr, MH, MM
• Collaborators: Tarumanagara University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Ulcer; Leprosy
• Other Study ID Numbers: PPZ20192072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No