NCT04134676

Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds

Completed Phase 1 Last updated 22 June 2020

What this trial tests

Phase 1 trial testing Conditioned Media in Chronic Ulcer in 38 participants. Completed in 10 June 2020.

Timeline

1 June 2019

Primary endpoint
10 May 2020

10 June 2020

Quick facts

Lead sponsor	Sukma Skin Treatment
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 June 2019
Primary completion	10 May 2020
Estimated completion	10 June 2020
Sites	3 locations across Indonesia

Drugs / interventions tested

• Conditioned Media — full drug profile →

Conditions studied

• Chronic Ulcer — all drugs for Chronic Ulcer →

Sponsor

Sukma Skin Treatment — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic wounds (CW) still represents a heavy burden to many patients and health care institution. Despite the most recent advances in wound management, up to 50% of chronic wounds still fail to heal. Conventional treatment of chronic wounds does not seem to work in several cases, consumes enormous amount of money and time, so it is necessary to develop different strategies. Previous studies have reported stem cells ability in tissue regenerations due mainly to its secreted paracrine factors, rather than its differentiation ability to become new cells. The factors is called secretomes, microvesicles, or exosomes, that can be found in the medium where the cells are growing, therefore it called conditioned medium (CM). Mesenchymal stem cells (MSCs) such as Wharton's Jelly Mesenchymal Stem Cells (WJ-MSC) appear to emerge as a promising wound healing therapy. To the best of investigator's knowledge, after conducted a pilot study using animal model to gain the preliminary data for the ulcer healing potential, this is the investigator's first clinical study to see the therapeutic potentials of Conditioned Medium Stem Cell as an additional growth factors in chronic skin ulcer healing and to compare the success of chronic ulcer healing in patients undergoing CM treatment and standard approach. The investigators will examine the therapeutic effect of human WJ-MSC-CM in wound healing on patients with chronic skin ulcer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical applications of stem cell-derived exosomes.
   Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0
2. Mesenchymal stem cell derived-exosomes: a modern approach in translational medicine.
   Nikfarjam S, Rezaie J, Zolbanin NM, Jafari R. · · 2020 · cited 309× · PMID 33246476 · DOI 10.1186/s12967-020-02622-3
3. Biomaterials functionalized with MSC secreted extracellular vesicles and soluble factors for tissue regeneration.
   Brennan MÁ, Layrolle P, Mooney DJ. · · 2020 · cited 288× · PMID 32952493 · DOI 10.1002/adfm.201909125
4. Therapeutic roles of mesenchymal stem cell-derived extracellular vesicles in cancer.
   Weng Z, Zhang B, Wu C, Yu F, et al · · 2021 · cited 282× · PMID 34479611 · DOI 10.1186/s13045-021-01141-y
5. Current Knowledge and Future Perspectives on Mesenchymal Stem Cell-Derived Exosomes as a New Therapeutic Agent.
   Joo HS, Suh JH, Lee HJ, Bang ES, et al · · 2020 · cited 206× · PMID 31979113 · DOI 10.3390/ijms21030727
6. Extracellular vesicles: a rising star for therapeutics and drug delivery.
   Du S, Guan Y, Xie A, Yan Z, et al · · 2023 · cited 168× · PMID 37475025 · DOI 10.1186/s12951-023-01973-5
7. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
8. Effects of Mesenchymal Stem Cell-Derived Paracrine Signals and Their Delivery Strategies.
   Chang C, Yan J, Yao Z, Zhang C, et al · · 2021 · cited 153× · PMID 33433956 · DOI 10.1002/adhm.202001689