Partial Thickness BurnPhase 4PHOENIXNCT07489560
Evaluation of Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft in Treatment of Partial Thickness Thermal Burns
A Phase 4 study testing Amnion-Intermediate-Chorion in people with Partial Thickness Burn, run by Cellution Biologics.
Trial summary
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Thickness Burn
- What is being tested?
- Amnion-Intermediate-Chorion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- One or more thermal burns classified as either superficial partial thickness or deep partial thickness.
- Total Body Surface Area (TBSA) involvement between 5% and 15%.
- Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )
- 1 If 2 or more burns are present, each must have an area greater than 15 cm 2
- The participant must be willing and able to participate in the informed consent process.
Who cannot join
- Full thickness burns.
- Burns present for \>72 hours prior to study evaluation
- Burns requiring immediate autografting.
- Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.
- Chemical or electrical burns.
- Burns secondary to blast injury.
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- Burns causing vascular or respiratory compromise and burns requiring escharotomy
- Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).
- Known coagulopathy, platelet disorder, INR \> 1.6, PTT \> 38s, or platelets \< 50,000 per mm 3
- Uncontrolled diabetes.
- Known life expectancy of \< 6 months.
- Evidence of active infection in burn.
- Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.
- Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)
- Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and/or are unwilling to utilize an appropriate form of contraception.
- Currently requiring dialysis or planning to start within 6 months.
- Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
- Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.
- Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Investigation Evaluating the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
- Conditions
- Partial Thickness Burn
- Being tested
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Keywords
- thermal burn, burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion-Intermediate-ChorionOther
Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)Procedure or surgery
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. Receives: Procedure: Standard of Care (SOC) |
| AIC and Standard of Care | Experimental | Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. Receives: Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Epithelialization
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Measured: 1-10 weeks
Secondary outcomes (5)
Percentage of Burn Area Change
To evaluate the difference in percentage reduction in burn wound area at each follow-up visit in participants receiving dHAICM versus SOC alone.
Measured: 1-10 weeks
Frequency of Full Epithelialization
To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.
Measured: 1-10 weeks
Changes in Pain Scores Associated with Target Burns
To determine the reduction in pain scores (VAS) for participants during dressing changes.
Measured: 1-10 weeks
Changes in Scarring Quality of Target Burn
To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS).
Measured: 1-10 weeks
Incidents of Adverse Events
To determine the difference in the frequency and nature of adverse events in participants receiving dHAICM versus SOC alone.
Measured: 1-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Change in company strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellution Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Cellution Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489560
- Sponsor's protocol ID
- CELLBIO-2026-002
- Acronym
- PHOENIX
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Clinical Investigation Evaluating the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns
- ClinicalTrials.gov ID
- NCT07489560
- Acronym / sponsor ID
- PHOENIX / CELLBIO-2026-002
- Conditions
- Partial Thickness Burn
- Keywords
- thermal burn, burn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in company strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cellution BiologicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of Care (SOC)Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. |
| AIC and Standard of Care | Experimental | Other: Amnion-Intermediate-Chorion, Procedure: Standard of Care (SOC)Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- One or more thermal burns classified as either superficial partial thickness or deep partial thickness.
- Total Body Surface Area (TBSA) involvement between 5% and 15%.
- Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )
- 1 If 2 or more burns are present, each must have an area greater than 15 cm 2
Key exclusion criteria (20 listed)
- Full thickness burns.
- Burns present for \>72 hours prior to study evaluation
- Burns requiring immediate autografting.
- Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.
- Chemical or electrical burns.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion-Intermediate-ChorionDehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast. | Other | AIC and Standard of Care |
| Standard of Care (SOC)Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance. | Procedure or surgery | AIC and Standard of Care, Standard of Care |
Primary outcome
Time to Complete Epithelialization
Time frame: 1-10 weeks
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
5 secondary outcomes
Percentage of Burn Area Change
Time frame: 1-10 weeks
Frequency of Full Epithelialization
Time frame: 1-10 weeks
Changes in Pain Scores Associated with Target Burns
Time frame: 1-10 weeks
Changes in Scarring Quality of Target Burn
Time frame: 1-10 weeks
Incidents of Adverse Events
Time frame: 1-10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Cellution Biologics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amnion-Intermediate-Chorion in people with Partial Thickness Burn, run by Cellution Biologics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Epithelialization (time frame: 1-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.