RECELL Clinical Education (Warning: Graphic Medical Images), page-31

While we patiently await the important numbers, I thought I'd check on the latest clinical research (ASCS = RECELL):

Benefits of Aerosolized, Point-of-care, Autologous Skin Cell Suspension (ASCS) for the Closure of full Thickness Wounds from Thermal and Non-Thermal Causes: Learning Curves from the first 50 Consecutive cases at an Urban, Level 1 Trauma Center

Published: 13 June 2024

Abstract

Objective: To determine the utility of Autologous Skin Cell Suspension (ASCS) in closing full-thickness (FT) defects from injury and infection.

Summary background data: Although ASCS has documented success in closing partial-thickness burns, far less is known about the efficacy of ASCS in FT defects.

Methods:Fifty consecutive patients with FT defects (burn 17, necrotizing infection 13, crush 7, degloving 5, other 8) underwent closure with the bilayer technique of 3:1 widely-meshed, thin, split-thickness skin graft and 80:1 expanded ASCS. End points were limb salvage rate, donor site reduction, operative and hospital throughput, incidence of complications, and re-epithelialization by 4, 8, and 12 weeks.

Results: Definitive wound closure was achieved in 76%, 94%, and 98% of patients, at 4, 8, and 12 weeks, respectively. Limb salvage occurred in 42/43 patients (10 upper, 33 lower extremities). Mean area grafted was 435 cm2; donor site size was 212 cm2, representing a potential reduction of 50%. Mean surgical time was 71 minutes; total OR time was 124 minutes. Mean length-of-stay was 26.4 days; time from grafting to discharge was 11.2 days. 4/50 patients (8%) required 6 reoperations for bleeding (1), breakdown (4), and amputation (1). 4/50 patients (8%) developed hypertrophic scarring, which responded to silicone sheeting (2) and laser resurfacing (2). Mean follow-up was 92.7 days.

Conclusion: When used for closure of FT wounds, point-of-care ASCS is effective and safe. Benefits include rapid re-epithelialization, high rate of limb salvage, reduction of donor site size and morbidity, and low incidence of hypertrophic scarring.

Biological attributes required for epidermal regeneration: Evaluation of the next-generation autologous cell harvesting device

First published: 11 June 2024

Abstract

Early wound intervention and closure is critical for reducing infection and improving aesthetic and functional outcomes for patients with acute burn wounds and nonthermal full-thickness skin defects. Treatment of partial-thickness burns or full-thickness injuries with autologous skin cell suspension (ASCS) achieves robust wound closure while limiting the amount of donor skin compared with standard autografting. A Next Generation Autologous Cell Harvesting Device (NG-ACHD) was developed to standardize the preparation process for ASCS to ensure biological attributes are obtained known to correlate with well-established safety and performance data. This study compared ASCS prepared using the NG-ACHD and ACHD following the manufacturer's guidance, evaluating cellular yields, viability, apoptotic activity, aggregates, phenotypes and functional capacity. Non-inferiority was established for all biological attributes tested and comparable healing trajectories were demonstrated using an in vitro skin regeneration model. In addition to standardization, the NG-ACHD also provides workflow efficiencies with the potential to decrease training requirements and increase the ease of incorporation and utilization of ASCS in clinical practice.

I think it's worth reading the full article to see the work that has gone into getting this technology FDA approved, as well as the additional marketing content like this:

In addition to providing a closed system to ensure a cell suspension having biological attributes known to result in positive clinical outcomes, the NG-ACHD also provides workflow efficiencies. These efficiencies are related to efforts involved in processing the samples as a 33% reduction in steps is realized with the NG-ACHD compared with the ACHD. This reduction will ease the training required in centers with non-dedicated OR staff or those with high staff-turn over. Additionally, the NG-ACHD decreases processing time for 24 cm2 tissue compared with the ACHD. In the NG-ACHD system, all skin can be placed and processed using one run of the device, whereas in the ACHD, two runs of enzymatic disaggregation and four runs of mechanical disaggregation are required. Although much of the preparation of the reagents and initiating enzymatic disaggregation remains consistent with the ACHD, the enzymatic and mechanical disaggregation steps are standardized for the end user.

806 Autologous Skin Cell Suspension Demonstrates Successful Outcomes in the Treatment of Burn and Wound Sites

Published: 17 April 2024

Abstract

Introduction

A new treatment paradigm increasing among burn and wound providers is the application of Autologous Skin Cell Suspension (ASCS). This system is a point-of-care therapy spraying on the patient's own cells promoting epidermal regeneration while reducing the amount of skin harvested for donor sites. Literature reports on the use of ASCS but there is a paucity of data describing the application of ASCS with temporal dermal substitutes and donor sites. The purpose of this study is to evaluate complex wound sites due to burns and other etiologies treated with ASCS solely or in combination with wound care applications. Also, a review of ASCS applied over donor sites is reported. We hypothesize the application of ASCS on complex wounds, burns and off-label usage on donor sites to demonstrate acceptable outcomes.

Methods

A retrospective chart review of burn and wound patients (N=53) treated with ASCS between 2019-2022 at a tertiary care center. Data was extracted from the electronic medical record. Treatments evaluated included ASCS only, ASCS with or without autologous split-thickness skin graft (STSG), and polyurethane bioabsorbable matrix (PBM) (I think this is Novosorb BTM - feel free to confirm or correct) placement prior to ASCS. Wound healing results were collected on the off-label use of ASCS applied to donor sites. Each individual wound site was measured (cm2) and failure rate was calculated based on size of dermal substrate or graft loss. Statistical analysis software was used to summarize data which included descriptive demographics, wound type/size, graft fail size, percent total burn, adjunct procedures, comorbidities, systemic/ local wound infection rate, complications, length of stay, and overall patient outcome summary.

Results

A total of 53 burn and wound patients were included, 46(87%) and 7(13%), respectively. The mean age was 44.3 (SD 20.6) years with 35(66%) patients being male. The mean total burn surface area was 30% (SD 23.8%). The most common comorbidities were hypertension, coronary artery disease and kidney disease. Highest complication was infection n=26 (49%), 11 local, 7 systemic and 8 both. A total of 577 injury sites were evaluated. The fail rate for PBM+STSG+ASCS, STSG+ASCS, ASCS+ non-donor site, and ASCS on donor site was (2.9%, 0.4%, 0.0%, 0.5%), respectively. No complications were reported with ASCS on donor sites. The percent fail of STSG’s without ASCS was 6.6% and reduced to 0.4% when used in combination with STSG+ASCS.

Conclusions

The findings of this study data demonstrate the successful application of ASCS even in the presence of infection on burn and complex wounds used alone or in conjunction with PBM. The results support the off-label use of ASCS on donor sites.

Applicability of Research to Practice

This study demonstrates the effectiveness of ASCS on wounds as well as the use on donor sites. This study adds to the growing literature evaluating the use of ASCS on burn wounds.


789 Six Year Experience with Autologous Skin Cell Suspension for Burn Wounds

Published: 17 April 2024

Abstract

Introduction

Autologous skin cell suspensions (ASCS) minimize the donor site required for addressing partial and full thickness burns. ASCS is currently FDA approved for use in combination with meshed split thickness skin grafts (STSGs) for full-thickness thermal burns in pediatric and adult patients. Besides the initial clinical trials of ASCS and STSG use for burn wounds, there are minimal studies reporting outcomes of their use. Here, we present our experience using ASCS in the past six years. We hypothesized that ASCS and STSG would result in a low reoperation and infection rate.

Methods

Retrospective review of patients seen at an American Burn Association verified burn center between 2017 and 2023 identified 15 patients treated with ASCS overlying STSG. Data collected included patient demographics, burn characteristics, surface area of ASCS usage, and patient outcomes. The primary outcome of interest was the requirement for reoperation following ASCS use. Secondary outcomes included hospital length of stay (LOS), ICU LOS, infection, and the necessity for scar revision via surgery or laser treatment. Data was analyzed using descriptive statistics with categorical variables presented as frequencies and percentages and continuous variables reported as medians and ranges.

Results

The median age of patients treated with ASCS was 36 years (13-67 years). The median BMI was 27.4 (17.7-35.4) and median total body surface area (TBSA) affected by burn was 18% (5.75-69.5%). Six patients (40%) had full thickness in addition to partial thickness burns. Most burns, 11 (73%) were the result of flames, although there were three grease burns and one friction burn. The median time to ASCS application was 10 days (1-39 days) and the median number of ASCS application sites was 2 (1-6). Most ASCS sites were on the upper or lower extremities or the torso; however, two patients had ASCS applied to their feet while another patient had it applied to their genitalia. Median ASCS surface area was 2,464 cm2 (289-20,000 cm2). Median LOS was 23 days (8-125 days) and median ICU LOS was 3 days (0-94 days). Four patients (26.7%) required reoperation on sites of ASCS application with the median time to reoperation being 40.5 days (28-66 days). Three patients (20%) required scar contracture surgery and three (20%) received laser treatments. There were no cutaneous infections in our cohort.

Conclusions

ASCS was effectively used to treat both partial thickness and full thickness burns and burns due to flame, grease, and friction. There did not seem to be any relationship between the necessity for reoperation after ASCS and the burn depth, etiology, surface area, or location.

Applicability of Research to Practice

Clinicians can look to our study for potential outcomes when using ASCS with STSG in a variety of situations.

716 Autologous Skin Cell Suspension for Dorsal Hand Burn Treatment

Published: 17 April 2024

Abstract

Introduction

Intermediate and deep partial-thickness dorsal hand burn injuries require timely and appropriate care to preserve both form and function. Split-thickness autografting (STAG) remains the standard of care but requires postoperative immobilization and a large donor site. Autologous skin cell suspensions (ASCS) are prepared from a small piece of autograft and are an alternative to STAG for partial thickness burns. They have minimal donor site morbidity and do not require postoperative immobilization. This study aims to assess the utility of ASCS in the treatment of intermediate and deep partial thickness burns of the dorsal hand.

Methods

This IRB-approved retrospective case series identified patients at a regional burn center with intermediate and deep partial-thickness hand burn injuries who were treated with ASCS alone. Data on injury etiology, demographic information, complications, functional variables, and treatment outcomes were collected.

Results

Ten male right-hand dominant patients with intermediate to deep partial thickness dorsal hand burns were identified, with a mean total body surface area involvement of 12.0±9.3%. On average, patients received ASCS alone for their hand burns on post-burn day 7.3±2.5. All ten patients resumed occupational therapy on postoperative day one. Nine patients had full upper extremity range of motion on day of discharge, which occurred on average 9.1±7.0 days after surgery. Four patients developed hypertrophic scarring without range of motion limitation of the ASCS treated hand. One patient experienced ASCS failure and required autografting for wound closure.

Conclusions

This retrospective case series presents ASCS as an effective wound closure strategy for intermediate to deep partial thickness hand burn injuries. In select patients, ASCS minimizes donor site morbidity and permits immediate upper extremity rehabilitation with excellent functional outcomes.

Applicability of Research to Practice

This research highlights the potential benefits of using ASCS for the treatment of dorsal hand burn injuries and thus suggests a possible change in current burn would management.

It's probably too early to get excited about this one yet, but I think this interview with Fiona Wood (no introduction needed) and Gordon Wallace is worth a listen:

How 3D printing is changing science fiction to fact

Broadcast Wed 17 Apr 2024 at 10:00pm

Below are some notes that I took (so might not be totally accurate) that indicates that they're incorporating RECELL in their 3D bioprinting research:

[Gordon Wallace]: “3D bioprinting takes us to a new level because now we’re looking at can we introduce living cells into those 3D printed structures”

[Fiona Wood]: “We can harvest the cells; we’ve developed the systems for harvesting the cells and that’s been in commercial space for 20 years now” (i.e., RECELL)

[Gordon Wallace]: “Imagine an ink in a printer, in a cartridge, and that ink has got cells in it and there’s also a biomaterial within that, usually a biopolymer, which will suspend the cells within ink so as we get a nice distribution for the print. That biopolymer has a number of roles; it keeps the cells dispersed, protects the cells during the printing and then provides the right environment after printing so as the cells can develop in an appropriate way”

“The secret to keeping it (the cells) alive in many of our applications is to integrate it with biology. So for example, if we’re trying to look at skin regeneration, we need to take that 3D printed structure and create it where we need it to integrate with biology and facilitate that regeneration”

[Fiona Wood]: “Can we spray the cells on with materials that self-assemble so they guide the cells in-situ. We’re printing in our experimental work actually into wounds. And so, we’re printing, the idea is at the point of care. And then the cells will be guided by the framework that we’ve printed so they’ll produce and regenerate skin so it’s very exciting”

“We really need to get it (the wound) healed within a week, that’s the goal. And certainly, we’re looking like we’re very close to that. 7-10 days.”

[Gordon Wallace]: “The fact that you can arrange materials and cells in 3-dimensions with exquisite control over where they are just changes the way you think about those treatments. And as Fiona said, if we can do that in-situ, basically with a handheld printer to print directly into the wound, that takes it to another level.”

[Fiona Wood]: “First-in-human work is all really on target I think for next year (2025)”

Q: In your opinion this is the future of skin grafting?

[Fiona Wood]: "In my opinion, yes."