What is the mechanism of action of this treatment?

Common treatments for skin wounds, such as autologous skin grafts, involve using the patient's own skin cells to promote healing. The Autologous Regeneration of Tissue (ART) device collects skin grafts from the patient's own skin, which are then applied to the wound site. This approach leverages the body's natural healing processes, reducing the risk of rejection and infection, and can accelerate wound healing while improving the quality of the regenerated skin. This is important for patients as it offers a safer and potentially more effective method for wound recovery.

What side effects are associated with this type of intervention?

Common side effects of skin autografting and similar autologous treatments include pain at the donor site, infection, prolonged edema, and complications such as contour irregularities and necrosis or calcification of the grafted tissue. There is also a risk of morbidity at the donor site, and in rare cases, fat emboli can lead to severe complications like stroke and vision loss. These side effects highlight the need for careful consideration and monitoring during and after the procedure.

What prior FDA approvals exist?

The FDA has approved several treatments for skin wounds that involve advanced regenerative techniques. One notable approval is for the use of autologous skin grafts, where skin is harvested from the patient's own body to promote healing. Additionally, the FDA has approved biologic therapies such as platelet-rich plasma (PRP) and various stem cell treatments, which aim to enhance the body's natural healing processes. These therapies are designed to treat chronic wounds, burns, and other severe skin injuries by leveraging the patient's own cells to regenerate damaged tissue.

What other types of research exist?

Promising alternatives to ART for skin wound patients include bioengineered alternative tissues, which have shown significant advancements in managing diabetic wounds and chronic wounds by accelerating healing. Additionally, injectable soft tissue fillers like poly-L-lactic acid and polyacrylamide hydrogel have been used for tissue augmentation and may offer potential benefits in wound healing and tissue regeneration.

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Tissue Regeneration

ART Device for Skin Wound Healing

N/A

Waitlist Available

Led By Hadar Lev-Tov, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 56

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called ART that helps collect skin grafts from a patient's own skin. It is aimed at people who need skin grafts, such as those with burns or injuries. The device works by growing new skin from a small sample of the patient's own skin, which can then be used for healing.

Who is the study for?

This trial is for adults aged 18-90 with chronic wounds present for at least 30 days. Participants must be able to consent and cannot have leg lesions, significant arterial disease, need cancer treatment (except certain skin cancers), or be on immunosuppressants, radiation, cytotoxic agents. Pregnant women and those with conditions that may risk safety or study goals are excluded.

What is being tested?

The study is testing a new device called Autologous Regeneration of Tissue (ART) designed to collect skin grafts from the patient's own body to help heal chronic wounds.

What are the potential side effects?

Potential side effects might include discomfort at the graft collection site, infection risks due to open wounds, possible allergic reactions to materials in the ART device, and complications related to wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change of pain on harvesting of skin at donor site.

Time to healing of donor sites

Secondary study objectives

Histologic evaluation

Wound healing of recipient site

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment1 Intervention

The donor area will be anesthetized with injected local anesthesia, harvested with the ART device, and bandaged with an occlusive dressing. The skin harvested will be placed on the recipient wound area. The area will be bandaged will a non-stick silicone dressing (covered by appropriate primary and secondary dressings) and left intact for 1-7 days.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for skin wounds, such as autologous skin grafts, involve using the patient's own skin cells to promote healing. The Autologous Regeneration of Tissue (ART) device collects skin grafts from the patient's own skin, which are then applied to the wound site. This approach leverages the body's natural healing processes, reducing the risk of rejection and infection, and can accelerate wound healing while improving the quality of the regenerated skin. This is important for patients as it offers a safer and potentially more effective method for wound recovery.

Autologous cell therapy in diabetes‑associated critical limb ischemia: From basic studies to clinical outcomes (Review).Autologous keratinocyte suspension in platelet concentrate accelerates and enhances wound healing - a prospective randomized clinical trial on skin graft donor sites: platelet concentrate and keratinocytes on donor sites.