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 helps 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 10cm2 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 1cm2 and her pain had been reduced significantly.[13]

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

  • Rashid et al. Wound Repair Regen. A pilot feasibility study of non-cultured autologous skin cell suspension for healing diabetic foot ulcers . 2020 Nov;28(6):719-727.
    https://onlinelibrary.wiley.com/doi/full/10.1111/wrr.12844
  • Hayes PD, Harding KG, Johnson SM, et al. A pilot multi-centre prospective randomised controlled trial of RECELL® for the treatment of venous leg ulcers. Int Wound J. 2020; 1–11. https://doi.org/10.1111/iwj.13293
  • 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/
  • 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.
  • 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.
  • 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/
  • POSTER: Hayes. The effectiveness of autologous cell suspensions to elicit positive changes in quality of life in patients with venous leg ulcers. European Wound Management Association (EMWA). 2016.
  • POSTER: O’Neill. Use of Autologous Skin Cell Suspensions to Heal Complex Chronic Wounds. European Wound Management Association (EMWA). 2016.
  • 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/
  • 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
  • POSTER: Woodrow. Experience with autologous skin cell suspension in a complex foot wound. College of Podiatry. 2015.
    https://pubmed.ncbi.nlm.nih.gov/23445302/
  • PRESENTATION: Woodrow. Experience with Autologous Skin Cell Suspension (ASCS) in a Complex Foot Wound. European Wound Management Association (EMWA). 2015.
  • POSTER: Curran. The Study Design of a Pilot Randomised Controlled trial of RECELL® for the Treatment of Venous Leg Ulcers. Wounds UK. 2014.
  • 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/
  • 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/
  • 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/
  • 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
  • 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
  • PRESENTATION: Giraldi. The difficult wound made easy. The use of non-cultured autologous cell suspension for the treatment of non-healing vascular ulcers of the lower limbs. Italian Association for the Study of Cutaneous Ulcers (AIUC). 2012.
  • Prompers L, 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/

IMPORTANT SAFETY INFORMATION (United States)

INDICATIONS FOR USE: The RECELL® Autologous Cell Harvesting Device is indicated for the treatment of acute thermal burn wounds. The RECELL® device is used by an appropriately-licensed healthcare professional at the patient’s point of care to prepare autologous RES® Regenerative Epidermal Suspension for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients.

CONTRAINDICATIONS: RECELL® is contraindicated for: the treatment of wounds clinically diagnosed as infected or with necrotic tissue, the treatment of patients with a known hypersensitivity to trypsin or compound sodium lactate (Hartmann’s) solution, patients having a known hypersensitivity to anesthetics, adrenaline/epinephrine, povidone-iodine, or chlorhexidine solutions.

WARNINGS AND PRECAUTIONS: Autologous use only. Wound beds treated with a cytotoxic agent (e.g., silver sulfadiazine) should be rinsed prior to application of the cell suspension. RECELL® is provided sterile and is intended for single-use. Do not use if packaging is damaged or expired. Choose a donor site with no evidence of cellulitis or infection and process skin immediately. A skin sample should require between 15 and 30 minutes contact with Enzyme. Contact in excess of 60 minutes is not recommended. RECELL® Enzyme is animal derived and freedom from infectious agents cannot be guaranteed.

PRECAUTIONS: RECELL® is not intended for use without meshed autograft for treatment of full-thickness burn wounds. The safety and effectiveness of RECELL® without meshed autograft have not been established for treatment of partial-thickness burn wounds: on the hands and articulating joints, >320 cm2, in patients with wounds totaling >20% total body surface area (TBSA). The safety and effectiveness of RECELL with autografting have not been established for treatment of full-thickness burn wounds: on the hands and articulated joints, and in patients younger than 28 days of age (neonates).

SPECIAL PATIENT POPULATIONS: The safety and effectiveness of RECELL® have not been established for treatment of acute thermal partial-thickness burn wounds in pediatric patients younger than 18 years of age.

For complete Important Safety Information, refer to Instructions For Use. Please be aware that any indication for RECELL® outside of the United States may differ from the US indication. Please see the Instructions for Use for each country for the specific indication of RECELL®.

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©Copyright 2022 AVITA Medical. All Rights Reserved.
Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to AVITA, its subsidiaries or affiliates. No use of any AVITA trademark, trade name, or trade dress in this site may be made without the prior written authorization of AVITA, except to identify the product or services of the company.
©Copyright 2022 AVITA Medical. All Rights Reserved.