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Cell Therapy

StrataGraft for Severe Burns (StrataSOMA Trial)

Phase 2
Waitlist Available
Research Sponsored by Stratatech, a Mallinckrodt Company
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 at month 12
Awards & highlights

StrataSOMA Trial Summary

This trial is testing a new product, StrataGraft, to see if it is a safe and effective treatment option for severe burns. The trial will compare StrataGraft to the standard treatment, meshed autograft.

Who is the study for?
This trial is for individuals with 2% to 49% total body surface area thermal burns needing skin grafts. Participants must consent, meet health and contraception criteria, and be able to follow study procedures for about 14 months. It's not for those with inhalation injuries, non-thermal burns, prisoners, pregnant women, or recent participants in other trials.Check my eligibility
What is being tested?
The trial tests a new treatment option that might use less donor skin for severe burns. Everyone gets standard meshed autograft on one burn part (AG Tx). On another part they get more widely meshed autograft covered by StrataGraft (SOMA Tx) to compare effectiveness.See study design
What are the potential side effects?
Potential side effects may include pain at the donor site, risk of infection or scarring there, and possible complications from additional surgeries required due to treatment problems.

StrataSOMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Durable Wound Closure of the Study Treatment Sites Without Additional Autografting at Month 12
Number of Treatment Sites with Complete Wound Closure Without Additional Autografting at Month 2

Side effects data

From 2009 Phase 3 trial • 840 Patients • NCT00671502
13%
somnolence
4%
dizziness
4%
nausea
2%
fatigue
1%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Tablet
Carisoprodol 500mg Tablet
Carisoprodol 700mg

StrataSOMA Trial Design

1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment2 Interventions
Each participant will receive both treatments. On each participant, similar wounds will be identified as treatment sites. Treatment sites will be randomized to receive either AG Tx (control) or SOMA Tx (experimental).

Find a Location

Who is running the clinical trial?

Stratatech, a Mallinckrodt CompanyLead Sponsor
8 Previous Clinical Trials
183 Total Patients Enrolled
Clinical Team LeaderStudy DirectorStratatech, a Mallinckrodt Company
23 Previous Clinical Trials
4,397 Total Patients Enrolled

Media Library

AG Tx (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04765202 — Phase 2
Full Thickness Burns Research Study Groups: All participants
Full Thickness Burns Clinical Trial 2023: AG Tx Highlights & Side Effects. Trial Name: NCT04765202 — Phase 2
AG Tx (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04765202 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants will be included in this trial?

"In order to properly assess the efficacy of this medication, 40 participants are needed who meet the pre-determined inclusion criteria. Fortunately, there are many sites where patients can take part in this trial, such as Stony Brook University and University of Iowa Hospitals and Clinics."

Answered by AI

Are there any opportunities for new patients to join this clinical trial?

"Yes, this information is accurate according to the website clinicaltrials.gov. This particular trial is still recruiting patients and originally posted on 5/28/2021 with updates as recent as 10/28/2022."

Answered by AI

Has the AG Tx medication received government approval for use?

"Because this is a phase 2 trial, meaning that while there is some data supporting safety, there is no data yet to support efficacy, our team has given AG Tx a score of 2."

Answered by AI

Is this a novel clinical trial?

"AG Tx has been researched since 2021, with the first study being sponsored by Stratatech. This initial research project was completed in 40 subjects. AG Tx then progressed to its Phase 2 drug approval stage. As of today, there is a single active trial for AG Tx being sponsored by Stratatech."

Answered by AI

Can I join this research project if I meet the requirements?

"The ideal candidate for this trial is somebody aged 18-75 that has suffered a full thickness burn over 2-49% of their body. Other key inclusion criteria are the ability to comply with study procedures and a willingness to do so."

Answered by AI

If a patient is above the age of 25, will they still be able to participate in this experiment?

"The aim of this study is to enroll patients that fall in the age bracket of 18 years or older, and 75 years or younger."

Answered by AI

Do we have a broad range of options for patients seeking this treatment in Canada?

"As of right now, this trial is still looking for participants from 9 different sites. These locations include Stony Brook, Iowa City and Portland as well as 6 other cities. If you enroll in this study, it would be best to select the site closest to your home to limit travel demands."

Answered by AI

What is the general research consensus on AG Tx?

"Currently, there is 1 active study and 0 Phase 3 trials researching AG Tx. The majority of these studies are situated in Winston-Salem, North carolina; however, AG Tx research is being conducted at 11 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
2021. "StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04765202.
~2 spots leftby Dec 2024
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