Pipeline: Clinical Trials

ONGOING CLINICAL TRIALS

We are currently exploring the potential of our novel technology platform to harness the regenerative properties of a patient’s own skin across a number of dermatological indications.

Supported by a substantive body of clinical evidence and peer-reviewed publications, our late stage pipeline is focused on injuries and skin defects leveraging the RECELL^® System.

AVITA Medical Clinical Trials

Current Clinical Trials

Repigmentation of Stable Vitiligo Lesions

Click here for more information about eligibility and enrollment in AVITA Medical’s Vitiligo Clinical Study.

Multi-Arm Clinical Study to Investigate the Safety and Effectiveness of RECELL^® for Repigmentation of Stable Vitiligo Lesions

Study: NCT04547998 on clinicaltrials.gov

Feasibility Study to Evaluate RECELL^® and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions

Study: NCT04271501 on clinicaltrials.gov.

Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Click here for more information about eligibility and enrollment in AVITA Medical’s Soft Tissue Clinical Study.

RECELL^® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

Study: NCT04091672 on clinicaltrials.gov.

Partial-thickness Burns in Ages 1-16 Years

RES^® Prepared With RECELL^® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years

Study: NCT03626701 on clinicaltrials.gov.

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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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.