A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial.
Shayan FarzanbakhshMohammad Amin ShahrbafHoda MadaniMostafa DahmardeiBahareh SadriAbdolhossein ShahverdiPublished in: Trials (2024)
Iranian Registry of Clinical Trials (IRCT) IRCT20080728001031N31, 2022-04-23 for phase I and IRCT20080728001031N36, 2024-03-15 for phase II.
Keyphrases
- phase ii
- clinical trial
- open label
- double blind
- phase iii
- stem cell transplantation
- placebo controlled
- bone marrow
- minimally invasive
- wound healing
- study protocol
- endothelial cells
- pet imaging
- hematopoietic stem cell
- randomized controlled trial
- low dose
- computed tomography
- stem cells
- high dose
- mesenchymal stem cells
- positron emission tomography