NCT02619851

A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects

Completed Phase 2 Last updated 25 August 2023

What this trial tests

Phase 2 trial testing ALLO-ASC-DFU in Burn Injury in 20 participants. Completed in 13 July 2021.

Timeline

23 December 2015

Primary endpoint
2 July 2019

13 July 2021

Quick facts

Lead sponsor	Anterogen Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	23 December 2015
Primary completion	2 July 2019
Estimated completion	13 July 2021
Sites	1 location across South Korea

Drugs / interventions tested

• ALLO-ASC-DFU — full drug profile →
• Conventional Therapy — full drug profile →

Conditions studied

• Burn Injury — all drugs for Burn Injury →

Sponsor

Anterogen Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Burn Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.

Publications & conference data

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

1. Advancements in Regenerative Strategies Through the Continuum of Burn Care.
   Stone Ii R, Natesan S, Kowalczewski CJ, Mangum LH, et al · · 2018 · cited 73× · PMID 30038569 · DOI 10.3389/fphar.2018.00672
2. Mesenchymal stem cell-based therapy for burn wound healing.
   Wang M, Xu X, Lei X, Tan J, et al · · 2021 · cited 47× · PMID 34212055 · DOI 10.1093/burnst/tkab002
3. Application of Adipose-Tissue Derived Products for Burn Wound Healing.
   Malekzadeh H, Tirmizi Z, Arellano JA, Egro FM, et al · · 2023 · cited 14× · PMID 37765109 · DOI 10.3390/ph16091302
4. Advancements in cell-based therapies for thermal burn wounds: a comprehensive systematic review of clinical trials outcomes.
   Yassaghi Y, Nazerian Y, Niazi F, Niknejad H. · · 2024 · cited 11× · PMID 39227861 · DOI 10.1186/s13287-024-03901-2
5. The Myofibroblast Fate of Therapeutic Mesenchymal Stromal Cells: Regeneration, Repair, or Despair?
   Younesi FS, Hinz B. · · 2024 · cited 7× · PMID 39201399 · DOI 10.3390/ijms25168712
6. Autologous fat grafting and adipose-derived stem cells therapy for acute burns and burn-related scar: A systematic review.
   Lesmanawati FE, Windura CA, Saputro ID, Hariani L. · · 2024 · cited 2× · PMID 38645780 · DOI 10.4103/tcmj.tcmj_189_23
7. An overview of stem cells and cell products involved in trauma injury.
   Saeedi P, Nilchiani LS, Zand B, Hajimirghasemi M, et al · · 2025 · cited 1× · PMID 40143930 · DOI 10.1016/j.reth.2025.02.011
8. Encapsulation of Adipose-Derived Stem Cells in Collagen-Based Hydrogel: Regenerative Therapy for Burn Wound Healing.
   Sitoresmi AAIA, Evananda MPS, Asmarajaya AAGN. · · 2025 · PMID 40498975 · DOI 10.1097/sap.0000000000004418