NCT02469168 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Moiemen NS, Vlachou E, Staiano JJ, Thawy Y, Frame JD
Reconstructive surgery with Integra dermal regeneration template: histologic study, clinical evaluation, and current practice. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):160S-174S.
Waaijman T, Breetveld M, Ulrich M, Middelkoop E, Scheper RJ, Gibbs S
Use of a collagen-elastin matrix as transport carrier system to transfer proliferating epidermal cells to human dermis in vitro. Cell Transplant. 2010;19(10):1339-48. doi: 10.3727/096368910X507196. Epub 2010 Jun 3.
Wood FM, Giles N, Stevenson A, Rea S, Fear M
Characterisation of the cell suspension harvested from the dermal epidermal junction using a ReCell® kit. Burns. 2012 Feb;38(1):44-51. doi: 10.1016/j.burns.2011.03.001. Epub 2011 Nov 12.
Wood FM, Stoner ML, Fowler BV, Fear MW
The use of a non-cultured autologous cell suspension and Integra dermal regeneration template to repair full-thickness skin wounds in a porcine model: a one-step process. Burns. 2007 Sep;33(6):693-700. Epub 2007 May 7.

Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Skin Cell Harvesting Device in Combination With Widened Meshed Autograft Applied Over Bilayered Wound Matrix

Details for clinical trial NCT02469168

Clinical trial NCT02469168 - References