Pipeline: Chronic Wounds

ONGOING RESEARCH EXPLORING POTENTIAL APPLICATION IN CHRONIC WOUNDS

A significant amount of chronic wounds, such as diabetic foot ulcers and venous leg ulcers, fail to heal, which can lead to pain, drainage, odor and infection as well as impacting quality of life. [1], [2] In the U.S., 49% of all skin grafts are for chronic wounds. [3]

Ongoing research with the RECELL® System for the treatment of chronic wounds help share experiences among the medical community. Below are select case studies provided as background. For general information about our science and technology, please contact our Medical Affairs team.

CASE STUDY: Venous Leg Ulcer Chronic Wound

A 67 year-old female patient presented with peripheral arterial disease, controlled type II diabetes and a 10 centimeters square VLU above her right ankle that had been open for 46 weeks. Treatment with Spray-On Skin™ Cells introduced healthy skin cells, representing all normal phenotypes and wound healing factors to overcome the dysfunctional cell processes and cellular signaling that had impaired the healing of her wound. At 13 weeks post-treatment, the patient’s wound had decreased to less than 1 centimeter square and her pain had been reduced significantly.

AVITA Medical venous leg ulcer baseline

BASELINE 1

AVITA Medical venous leg ulcer week 6

6 WEEKS

POST-RECELL® TREATMENT

AVITA Medical venous leg ulcer week 13

13 WEEKS

POST-RECELL® TREATMENT

Caution: The use of RECELL® as a treatment of chronic wounds is limited by U.S. law to investigational use.

The RECELL® System is apprpoved by the U.S. Food and Drug Administration (FDA) for the treatment of acute thermal burns in patients 18 years and older. Click here for Important Safety and Information and Instructions for Use.


ADDITIONAL RESEARCH: Abstracts, Posters, Presentations

  1. Hayes et al. Int Wound J. A Pilot Multi-Centre Prospective Randomised Controlled Trial of RECELL for the Treatment of Venous Leg Ulcers. 2020 April;10.1111/iwj.13293. doi:10.1111/iwj.13293
    https://pubmed.ncbi.nlm.nih.gov/32103603/
  2. Hu et. al. BJS. Randomized clinical trial of autologous skin cell suspension combined with skin grafting for chronic wounds. 2015 Jan;102(2):e117-23
    https://pubmed.ncbi.nlm.nih.gov/25627123/
  3. De Angelis et. al. Int Wound J. The use of a non-cultured autologous cell suspension to repair chronic ulcers. 2015 Feb;12(1):32-9
    https://pubmed.ncbi.nlm.nih.gov/23445302/
  4. Giraldi et. al. Acta Vulnologica. Preliminary results with the use of a non-cultured autologous cell suspension to repair non-healing vascular leg ulcers. 2012;10(3):153-63
    https://www.minervamedica.it/en/journals/acta-vulnologica/article.php?cod=R45Y2012N03A0153
  5. Chant et. al. J Wound Care. Autologous skin cells: a new technique for skin regeneration in diabetic and vascular ulcers. 2013 Oct;22(10 Suppl):S11-15
    https://pubmed.ncbi.nlm.nih.gov/24142135/
  6. Jackson et. al. Ann R Coll Surg Engl. Combined use of hyperbaric oxygen and sprayed keratinocyte suspension to tackle a difficult wound. 2014 Sep;96(6):e20-2
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4474222/
  7. Trapasso et. al. Plast Reconstr Surg Glob Open. Regenerative surgery for the definitive repair of a vasculitic nonhealing ulcer using platelet-derived growth factors and noncultured autologous cell suspension. 2013 Jun 7;1(2):1-3
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4184053/
  8. Presentation: Z Hu. Randomized Clinical Trial of Autologous Skin Cell Suspension Combined with Grafting for Chronic Wounds. 2018 November 30-December 1; ISBI; New Delhi, India.
  9. Presentation: T Rashid. A Feasibility Study of the RECELL® Autologous Cell Harvesting Device for Diabetic Foot Ulcers. 2019 June 28-29; The congress of the Japan Society of Limb Salvage & Podiatric Medicine (JSLSPM)​; Kobe, Japan.
  10. White, Richard & Brown, Annemarie. (2013). Debate: Nonhealing venous leg ulcers in primary care: Clinical significance of training, knowledge, treatment, and healing. Wounds UK. 9:12-14.
    https://www.woundsinternational.com/uploads/resources/content_10765.pdf
  11. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008;51(5):747-755. doi:10.1007/s00125-008-0940-0
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2292424/
  12. Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018;1411(1):153-165. doi:10.1111/nyas.13569
    https://pubmed.ncbi.nlm.nih.gov/29377202/
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