Epidermolysis Bullosa (EB)Phase 4NCT07717736
Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds
A Phase 4 study testing Non-conforming pz-cel surgical application to RDEB wounds, Additional biopsies and Pz-cel surgical application to DEB wounds in people with Epidermolysis Bullosa (EB) and Recessive Dystrophic Epidermolysis Bullosa (RDEB), run by Abeona Therapeutics, Inc.
Trial summary
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel and related processes in the post-marketing setting. Study A investigates the efficacy and safety of non-conforming pz-cel in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB), Dystrophic Epidermolysis Bullosa (DEB)
- What is being tested?
- Non-conforming pz-cel surgical application to RDEB wounds, Additional biopsies and Pz-cel surgical application to DEB wounds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.
- Patients who are expected to receive pz-cel manufactured as intended for commercial treatment; however, the final manufactured product was non-conforming and therefore did not meet commercial release criteria.
- All women of childbearing potential should discuss reproductive and breastfeeding plans and precautions with the treating physician in accordance with the considerations for special populations in the United States Prescribing Information (USPI).
- Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.
- Patients who are expected to receive treatment with pz-cel and are receiving a biopsy prior to pz-cel application in the post-marketing setting.
- Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.
- Patients who were prescribed pz-cel for commercial treatment but require special access defined in the protocol for treatment to occur.
- All women of childbearing potential must have a negative urine pregnancy test and agree to use a reliable birth control method throughout the duration of the study.
Who cannot join
- Inability to adequately follow the protocol and ensure the protection of cellular sheet sites, as determined by the Investigator.
- Hypersensitivity to vancomycin or amikacin.
- The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as, but not limited to, active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Evidence of systemic infection.
- Current evidence of squamous cell carcinoma (SCC) in the area that will undergo pz-cel application.
- Grade 3 clinical event or laboratory abnormality prior to pz-cel treatment, with the exception of abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch, which are expected in patients with severe DEB.
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- Any other circumstance where the Investigator believes that it is not appropriate for the patient to participate in the study.
- Study B
- 1. Any circumstance where the Investigator believes that the patient may not be appropriate for participation in the study.
- Study C
- Inability to properly follow protocol assessments and protect cellular sheet sites as determined by the Investigator.
- Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat DEB or receipt of the investigational therapy within the 3 months prior to pz-cel application.
- Breastfeeding.
- The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as, but not limited to, active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Evidence of systemic infection.
- Current evidence or a history of SCC in the area that will undergo pz-cel application.
- Active drug or alcohol addiction.
- Hypersensitivity to vancomycin or amikacin.
- Grade 3 clinical event or laboratory abnormality prior to pz-cel treatment, with the exception of abnormalities such as esophageal strictures, anemia, low albumin, and pain/itch, which are expected in patients with severe DEB.
- Any other circumstance where the Investigator believes that it is not appropriate for the patient to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel and related processes in the post-marketing setting.
Study A investigates the efficacy and safety of non-conforming pz-cel in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).
Study B enables the collection of additional biopsy samples from patients receiving treatment with pz-cel.
Study C assesses the efficacy and safety of pz-cel in patient populations not represented in the VIITAL clinical trial (NCT04227106).
Read the detailed description
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel (LZRSE-COL7A1 gene-corrected cellular sheets with type VII collagen [C7] expression) and related processes in the post-marketing setting.
Pz-cel is a genetically engineered autologous cell therapy indicated for the treatment of wounds associated with RDEB. Pz-cel is composed of autologous keratinocytes from patients with mutations in the collagen type VII alpha 1 chain (COL7A1) gene, which have been transduced ex vivo with the Moloney leukemia virus-derived retroviral vector (LZRSE)-COL7A1. The gene-corrected cellular sheets express functional C7.
The pz-cel sheets are a one-time surgical application to debrided and cauterized wound beds of the corresponding patients with DEB. The COL7A1 transgene integrates into the host cell genome, resulting in durable expression and secretion of collagen protein, which addresses the underlying mechanism of the disease.
Study A is an open-label, non-randomized study in patients who are expected to receive gene-corrected cellular sheets (pz-cel) for the treatment of RDEB wound sites in the post-marketing setting and whose manufactured patient-specific batch of pz-cel intended for commercial treatment did not meet commercial release criteria, but had no safety concerns associated with its use. This study will allow surgical application of such non-conforming pz-cel when the benefit of application outweighs the risks. All patients will be followed through 24 weeks after treatment and may be eligible for further follow-up after Week 24. Patients will be evaluated at their Screening visit (30 days before surgery), at Day 0 (Surgery day), by phone on Week 4 (Month 1) and by Telehealth or Clinic Visit at Week 12 (Month 3) and Week 24 (Month 6).
Study B is a study to collect additional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting. The additional biopsy samples are being collected to support pz-cel product optimization. Patients receiving treatment with pz-cel can consent to have 2 additional 8-mm biopsies for use in the pz-cel assay and process development as well as in the optimization of the pz-cel manufacturing processes. The study will consist of Screening (in-person or via phone and eConsent), a pre-surgery biopsy and an End of Study Phone call 10-14 days after biopsy.
Study C is an open-label, non-randomized study in patients who are prescribed gene-corrected cellular sheets (pz-cel) in the post-marketing setting and who are part of a patient population not represented in the VIITAL Clinical Trial (NCT04227106). This study will enable patients with wounds that could benefit from treatment with pz-cel, especially those requiring special access for application of pz-cel, to receive pz-cel. All patients will be followed through 24 weeks after treatment and may be eligible for further follow-up after Week 24. Patients will be evaluated at their Screening visit (25-60 days before surgery), at Day -1 (one day prior to surgery), at Day 0 (Surgery Day), by phone on Week 4 (Month 1) and by Telehealth or Clinic Visit at Week 12 (Month 3) and Week 24 (Month 6).
- Conditions
- Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB), Dystrophic Epidermolysis Bullosa (DEB)
- Being tested
- Non-conforming pz-cel surgical application to RDEB wounds, Additional biopsies, Pz-cel surgical application to DEB wounds
- Medical subject headings
- Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-conforming pz-cel surgical application to RDEB woundsBiological
Non-conforming pz-cel is pz-cel intended for commercial treatment that did not meet commercial release criteria, but had no safety concerns associated with its use.
Additional biopsiesProcedure or surgery
Additional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting.
Pz-cel surgical application to DEB woundsBiological
This intervention is for patients requiring special access for application of pz-cel.
| Study group | Role | What they receive |
|---|---|---|
| Study A | Experimental | Clinical Evaluation of Prademagene Zamikeracel (Pz-cel) Treatment in Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) Who Were Prescribed Pz-cel and Received Non-conforming Pz-cel in the Post-marketing Setting Receives: Biological: Non-conforming pz-cel surgical application to RDEB wounds |
| Study B | Other | Tissue Collection Study for Patients Undergoing Biopsies for Treatment With Prademagene Zamikeracel (Pz-cel) Receives: Procedure: Additional biopsies |
| Study C | Experimental | Post-Marketing Pz-cel Access Study in Dystrophic Epidermolysis Bullosa (DEB) Evaluating Patient Populations Not Represented in the VIITAL Clinical Trial (NCT04227106) Receives: Biological: Pz-cel surgical application to DEB wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study A - Wound Healing ≥50%
Proportion of RDEB wounds with healing ≥50% from Baseline at Week 24 (Month 6) as determined by direct Investigator assessment.
Measured: From Baseline at Week 24 (Month 6)
Study A - Pain Severity Scale (Wong-Baker FACES)
Pain reduction assessed by the Wong-Baker FACES Pain Rating Scale (for patients ≥6 years of age) at Week 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Week 24 (Month 6)
Study C - Wound Healing ≥50%
Proportion of wounds with healing ≥50% from Baseline at Week 24 (Month 6) as determined by direct Investigator assessment.
Measured: From Baseline at Week 24 (Month 6)
Study C - Pain Severity Scale (Wong-Baker FACES)
Pain reduction assessed by Wong-Baker FACES Pain Rating Scale (for patients ≥6 years old) at Week 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Week 24 (Month 6)
Secondary outcomes (10)
Study A - Wound Healing ≥50%
Proportion of RDEB wounds with ≥50% healing at Week 12 (Month 3) as determined by direct Investigator assessment.
Measured: At Week 12 (Month 3)
Study A - Wound Healing ≥75%
Proportion of RDEB wounds with ≥75% healing at Weeks 12 (Month 3) and 24 (Month 6) as determined by direct Investigator assessment.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Study A - Wound Healing Complete
Proportion of RDEB wounds with complete healing (i.e., re-epithelialization with no drainage or erosion and presence of only minor crusting) at Weeks 12 (Month 3) and 24 (Month 6) as determined by direct Investigator assessment.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Study A - Pain Severity Scale (Wong-Baker FACES)
Pain reduction assessed by the Wong-Baker FACES Pain Rating Scale (for patients ≥6 years of age) at Week 12 (Month 3). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Week 12 (Month 3)
Study A - Worst Itch Severity Scale
Change in scores of Worst Itch Numeric Rating Scale (WI-NRS; for patients ≥6 years of age) assessed at Weeks 12 (Month 3) and 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Wound Healing ≥50%
Proportion of DEB wounds with ≥50% healing at Week 12 (Month 3) as determined by direct Investigator assessment.
Measured: At Week 12 (Month 3)
Study C - Wound Healing ≥75%
Proportion of DEB wounds with ≥75% healing at Weeks 12 (Month 3) and 24 (Month 6) as determined by direct Investigator assessment.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Wound Healing Complete
Proportion of DEB wounds with complete healing (i.e., re-epithelialization with no drainage or erosion and presence of only minor crusting) at Weeks 12 (Month 3) and 24 (Month 6) as determined by direct Investigator assessment.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Pain Severity Scale (Wong-Baker FACES)
Pain reduction assessed by the Wong-Baker FACES Pain Rating Scale (for patients ≥6 years of age) at Week 12 (Month 3). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Week 12 (Month 3)
Study C - Worst Itch Severity Scale
Change in scores of WI-NRS (for patients ≥6 years of age) assessed at Weeks 12 (Month 3) and 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Measured: At Weeks 12 (Month 3) and 24 (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa (EB)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abeona Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717736
- Sponsor's protocol ID
- Pz-cel-CL-402
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds
- ClinicalTrials.gov ID
- NCT07717736
- Acronym / sponsor ID
- Pz-cel-CL-402
- Conditions
- Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB), Dystrophic Epidermolysis Bullosa (DEB)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abeona Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 21 Jul 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.
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel and related processes in the post-marketing setting.
Study A investigates the efficacy and safety of non-conforming pz-cel in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).
Study B enables the collection of additional biopsy samples from patients receiving treatment with pz-cel.
Study C assesses the efficacy and safety of pz-cel in patient populations not represented in the VIITAL clinical trial (NCT04227106).
Detailed description
The Master Protocol includes 3 studies (Study A, Study B, and Study C) that will evaluate pz-cel (LZRSE-COL7A1 gene-corrected cellular sheets with type VII collagen [C7] expression) and related processes in the post-marketing setting.
Pz-cel is a genetically engineered autologous cell therapy indicated for the treatment of wounds associated with RDEB. Pz-cel is composed of autologous keratinocytes from patients with mutations in the collagen type VII alpha 1 chain (COL7A1) gene, which have been transduced ex vivo with the Moloney leukemia virus-derived retroviral vector (LZRSE)-COL7A1. The gene-corrected cellular sheets express functional C7.
The pz-cel sheets are a one-time surgical application to debrided and cauterized wound beds of the corresponding patients with DEB. The COL7A1 transgene integrates into the host cell genome, resulting in durable expression and secretion of collagen protein, which addresses the underlying mechanism of the disease.
Study A is an open-label, non-randomized study in patients who are expected to receive gene-corrected cellular sheets (pz-cel) for the treatment of RDEB wound sites in the post-marketing setting and whose manufactured patient-specific batch of pz-cel intended for commercial treatment did not meet commercial release criteria, but had no safety concerns associated with its use. This study will allow surgical application of such non-conforming pz-cel when the benefit of application outweighs the risks. All patients will be followed through 24 weeks after treatment and may be eligible for further follow-up after Week 24. Patients will be evaluated at their Screening visit (30 days before surgery), at Day 0 (Surgery day), by phone on Week 4 (Month 1) and by Telehealth or Clinic Visit at Week 12 (Month 3) and Week 24 (Month 6).
Study B is a study to collect additional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting. The additional biopsy samples are being collected to support pz-cel product optimization. Patients receiving treatment with pz-cel can consent to have 2 additional 8-mm biopsies for use in the pz-cel assay and process development as well as in the optimization of the pz-cel manufacturing processes. The study will consist of Screening (in-person or via phone and eConsent), a pre-surgery biopsy and an End of Study Phone call 10-14 days after biopsy.
Study C is an open-label, non-randomized study in patients who are prescribed gene-corrected cellular sheets (pz-cel) in the post-marketing setting and who are part of a patient population not represented in the VIITAL Clinical Trial (NCT04227106). This study will enable patients with wounds that could benefit from treatment with pz-cel, especially those requiring special access for application of pz-cel, to receive pz-cel. All patients will be followed through 24 weeks after treatment and may be eligible for further follow-up after Week 24. Patients will be evaluated at their Screening visit (25-60 days before surgery), at Day -1 (one day prior to surgery), at Day 0 (Surgery Day), by phone on Week 4 (Month 1) and by Telehealth or Clinic Visit at Week 12 (Month 3) and Week 24 (Month 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study A | Experimental | Biological: Non-conforming pz-cel surgical application to RDEB woundsClinical Evaluation of Prademagene Zamikeracel (Pz-cel) Treatment in Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB) Who Were Prescribed Pz-cel and Received Non-conforming Pz-cel in the Post-marketing Setting |
| Study B | Other | Procedure: Additional biopsiesTissue Collection Study for Patients Undergoing Biopsies for Treatment With Prademagene Zamikeracel (Pz-cel) |
| Study C | Experimental | Biological: Pz-cel surgical application to DEB woundsPost-Marketing Pz-cel Access Study in Dystrophic Epidermolysis Bullosa (DEB) Evaluating Patient Populations Not Represented in the VIITAL Clinical Trial (NCT04227106) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.
- Patients who are expected to receive pz-cel manufactured as intended for commercial treatment; however, the final manufactured product was non-conforming and therefore did not meet commercial release criteria.
- All women of childbearing potential should discuss reproductive and breastfeeding plans and precautions with the treating physician in accordance with the considerations for special populations in the United States Prescribing Information (USPI).
- Willing and able to provide informed consent/assent; if under the age of 18, guardian(s) is (are) willing and able to provide consent.
- Patients who are expected to receive treatment with pz-cel and are receiving a biopsy prior to pz-cel application in the post-marketing setting.
Key exclusion criteria (20 listed)
- Inability to adequately follow the protocol and ensure the protection of cellular sheet sites, as determined by the Investigator.
- Hypersensitivity to vancomycin or amikacin.
- The presence of medical illness expected to complicate participation and/or compromise the safety of this technique, such as, but not limited to, active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Evidence of systemic infection.
- Current evidence of squamous cell carcinoma (SCC) in the area that will undergo pz-cel application.
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 |
|---|---|---|
| Non-conforming pz-cel surgical application to RDEB woundsNon-conforming pz-cel is pz-cel intended for commercial treatment that did not meet commercial release criteria, but had no safety concerns associated with its use. | Biological | Study A |
| Additional biopsiesAdditional biopsy samples from patients who are expected to receive treatment with pz-cel in the post-marketing setting. | Procedure or surgery | Study B |
| Pz-cel surgical application to DEB woundsThis intervention is for patients requiring special access for application of pz-cel. | Biological | Study C |
Primary outcome
Study A - Wound Healing ≥50%
Time frame: From Baseline at Week 24 (Month 6)
Proportion of RDEB wounds with healing ≥50% from Baseline at Week 24 (Month 6) as determined by direct Investigator assessment.
Study A - Pain Severity Scale (Wong-Baker FACES)
Time frame: At Week 24 (Month 6)
Pain reduction assessed by the Wong-Baker FACES Pain Rating Scale (for patients ≥6 years of age) at Week 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
Study C - Wound Healing ≥50%
Time frame: From Baseline at Week 24 (Month 6)
Proportion of wounds with healing ≥50% from Baseline at Week 24 (Month 6) as determined by direct Investigator assessment.
Study C - Pain Severity Scale (Wong-Baker FACES)
Time frame: At Week 24 (Month 6)
Pain reduction assessed by Wong-Baker FACES Pain Rating Scale (for patients ≥6 years old) at Week 24 (Month 6). The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
10 secondary outcomes
Study A - Wound Healing ≥50%
Time frame: At Week 12 (Month 3)
Study A - Wound Healing ≥75%
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Study A - Wound Healing Complete
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Study A - Pain Severity Scale (Wong-Baker FACES)
Time frame: At Week 12 (Month 3)
Study A - Worst Itch Severity Scale
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Wound Healing ≥50%
Time frame: At Week 12 (Month 3)
Study C - Wound Healing ≥75%
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Wound Healing Complete
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Study C - Pain Severity Scale (Wong-Baker FACES)
Time frame: At Week 12 (Month 3)
Study C - Worst Itch Severity Scale
Time frame: At Weeks 12 (Month 3) and 24 (Month 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-conforming pz-cel surgical application to RDEB wounds, Additional biopsies and Pz-cel surgical application to DEB wounds in people with Epidermolysis Bullosa (EB) and Recessive Dystrophic Epidermolysis Bullosa (RDEB), run by Abeona Therapeutics, Inc.
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 8 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: opening soon, as of the sponsor's last update on 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Iheanacho (646-813-7166, aiheanacho@abeonatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study A - Wound Healing ≥50% (time frame: From Baseline at Week 24 (Month 6)). The study lists 4 primary outcomes in all. 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 6 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.