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Trophic UlcerPhase 1NCT05777213

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

A Phase 1 study testing Secretome in people with Trophic Ulcer and Leprosy, run by Yohanes Firmansyah, dr, MH, MM at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Trophic Ulcer, Leprosy, Morbus Hansen
What is being tested?
Secretome
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesIndonesia
Study dates
1 Jan 2019to 2 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • RS Alverno Singkawang

    Singkawang, West Borneo, 79123

  • Sukma Clinic

    Tangerang, Banten, 15810

Other trials in Indonesia

About this study

Official title: 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

Being tested
Secretome
Keywords
CM-MSC, Stemcell, trophic ulcer, leprosy, morbus hansen, secretom
Medical subject headings
Leprosy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecretomeBiological

    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.

Study groups in NCT05777213
Study groupRoleWhat they receive
Conditioned Medium Wharton's Jelly-derived mesenchymal stem cells (CM-WJMSCs)ExperimentalConditioned 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.
Receives: Biological: Secretome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

  2. 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

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2022
  4. Study completion2 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777213
Sponsor's protocol ID
PPZ20192072
Status last verified
Mar 2026
First submitted
27 Feb 2023
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 25389921

  • 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.

    PubMed 25771459

  • 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.

    PubMed 31389998

  • 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.

    PubMed 22826694

  • 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.

    PubMed 16248209

  • 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.

    PubMed 25530971

  • 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.

    PubMed 25884704

  • 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.

    PubMed 21756569

  • 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.

    PubMed 28841158

  • 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.

    PubMed 31148869

  • 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.

    PubMed 22846185

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Secretome in people with Trophic Ulcer and Leprosy, run by Yohanes Firmansyah, dr, MH, MM at 2 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Wound Size - Length (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05777213, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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