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Epidermal Harvesting System
Cellutome System for Epidermolysis Bullosa
N/A
Waitlist Available
Led By Christen Ebens, MD, MPH
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) with at least one wound, visibly free from infection (or previously treated) and meets the eligibility for Arm A or Arm B based on the skin graft source
Peripheral blood donor chimerism should be measured within 21 days of grafting and be >/= 5% and stable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after grafting
Awards & highlights
Study Summary
This trial is testing a new way to treat wounds for people with a systemic genodermatosis epidermolysis bullosa (EB) by using epidermal skin grafting from the same donor that provided the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene corrected) skin.
Who is the study for?
This trial is for individuals with Epidermolysis Bullosa (EB) who have at least one wound suitable for treatment. Participants must be over 2 years old, off immune suppressive therapy, and have had a hematopoietic cell transplant from a donor or possess naturally gene-corrected skin. They should not have any infections or autoimmune issues pre-transplant and must consent to the procedure.Check my eligibility
What is being tested?
The study tests the Cellutome Epidermal Harvesting System on EB patients. It involves taking epidermal grafts either from their previous bone marrow donor or their own mosaic skin and applying it to wounds using a special vacuum device in hopes of achieving long-term healing.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include discomfort during the harvesting process, infection at the graft site, rejection of the epidermal grafts, or complications related to wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have DEB or JEB with at least one wound that is not infected.
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My blood test shows at least 5% donor cells after a transplant, and it's stable.
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I have never had autoimmune blood disorders before a bone marrow transplant.
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I am not on any immune-suppressing medications.
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My condition involves a genetic change that reversed a previous mutation.
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My skin grafting area is healthy and free from infections or abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after grafting
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after grafting
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Grafts Successfully Treated
Secondary outcome measures
Longevity of Grafted Skin
Participants With Lesion Free Skin
Percentage Change of a Patient's IScorEB Assessment Score
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Self donor from intact skin patchExperimental Treatment1 Intervention
Cells are harvested from the subject using Cellutome, then transferred via Adaptic dressing to that subject's wound with up to 3 harvest sites/treated wound sites on day 0.
Group II: Graft from HCT donorExperimental Treatment1 Intervention
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cellutome Epidermal Harvesting System
2016
N/A
~40
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,591 Total Patients Enrolled
3 Trials studying Epidermolysis Bullosa
56 Patients Enrolled for Epidermolysis Bullosa
Christen Ebens, MD, MPHPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person who donated the skin for the original transplant is able and willing to donate more skin.You have tested negative for Hepatitis B and C, HIV, and HTLV1/2 within the last 30 days.My previous stem cell transplant donor's cells can be used again.My blood donor match is stable and above 5% as checked within the last 3 weeks.I have DEB or JEB with at least one wound that is not infected.It's been over 6 months since my bone marrow transplant.My blood test shows at least 5% donor cells after a transplant, and it's stable.I have never had autoimmune blood disorders before a bone marrow transplant.I am not on any immune-suppressing medications.My condition involves a genetic change that reversed a previous mutation.My skin grafting area is healthy and free from infections or abnormalities.Criterion: This is not a complete criterion. Please provide more context or information.I am older than 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Graft from HCT donor
- Group 2: Self donor from intact skin patch
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for volunteers to partake in this research endeavor?
"According to the clinicaltrial.gov website, this experiment is no longer recruiting participants; it was initially posted on 4th August 2016 and last updated on 2nd November 2022. Nevertheless, 28 other medical studies are presently attempting to enroll patients in their research endeavours."
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