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The purpose of this clinical trial was to evaluate the safety and tolerability for 12 weeks after one dose of TRTP-101 in adults with atrophic scars.
A phase 1 clinical trial to evaluate dose-limiting toxicity by administering a singe dose of TRTP-101 to each of the four sites of atrophic scar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRTP-101 | Experimental | Micro-Block (MiB) manufactured from autologous Adipose-derived Mesenchymal Stem Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRTP-101 | Biological | Intradermal injection of the each of four sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity | Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101 | within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change in atrophic scar volume | The depressed volume of atropic scar is measured at baseline and post-treatment visits | 1, 4, 8 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonghee Lee, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33073298 | Background | Kwon HH, Yang SH, Lee J, Park BC, Park KY, Jung JY, Bae Y, Park GH. Combination Treatment with Human Adipose Tissue Stem Cell-derived Exosomes and Fractional CO2 Laser for Acne Scars: A 12-week Prospective, Double-blind, Randomized, Split-face Study. Acta Derm Venereol. 2020 Nov 4;100(18):adv00310. doi: 10.2340/00015555-3666. | |
| 23006344 |
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| Cho YB, Lee WY, Park KJ, Kim M, Yoo HW, Yu CS. Autologous adipose tissue-derived stem cells for the treatment of Crohn's fistula: a phase I clinical study. Cell Transplant. 2013;22(2):279-85. doi: 10.3727/096368912X656045. Epub 2012 Sep 21. |
| 25436715 | Background | Salloum RH, Rubin JP, Marra KG. The role of steroids in mesenchymal stem cell differentiation: molecular and clinical perspectives. Horm Mol Biol Clin Investig. 2013 Aug;14(1):3-14. doi: 10.1515/hmbci-2013-0016. |