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New treatment option for Dystrophic Epidermolysis Bullosa
Official title MSC EVs in Dystrophic Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT04173650
What this study is testing
What is AGLE-102?
AGLE-102 is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for dystrophic epidermolysis bullosa.
Also referred to as AGLE 102, Control.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- people must be 6 months or older at screening.
- people who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. people with severe DEB (e.g., RDEB...
- Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) at least 4 inches apart that can be considered similar enough in...
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening and agree to continue use of an acceptable form of...
- Post-pubertal males who agree to use an acceptable method of contraception for the duration of the study.
You likely can't join if
- Concomitant treatment at the time of screening or at any time during the study of either study wound (control or AGLE-102 treated) with local or...
- Either study wound located within 6 inches of wounds treated concurrently with any other local therapy.
- Clinical evidence of systemic infection.
- History of bone marrow transplantation.
- Diagnosed clinically significant autoimmune disease
- Wound that extends across the fingers, toes, pubic or perineum region are excluded from being index wounds.
See the full eligibility criteria
- people must be 6 months or older at screening.
- people who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. people with severe DEB (e.g., RDEB patients with absent Col VII/no anchoring fibrils) and milder forms of DEB...
- Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) at least 4 inches apart that can be considered similar enough in size, wound location and expected healing characteristics to be a...
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening and agree to continue use of an acceptable form of birth control throughout the duration of the study. Acceptable forms...
- Post-pubertal males who agree to use an acceptable method of contraception for the duration of the study.
- people 18 years of age and older must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. people...
- Willing to comply with the protocol requirements. Note: Reference to Appendix 3 can be located in the protocol
- Concomitant treatment at the time of screening or at any time during the study of either study wound (control or AGLE-102 treated) with local or systemic therapy other than standard of care treatments described in this...
- Either study wound located within 6 inches of wounds treated concurrently with any other local therapy.
- Clinical evidence of systemic infection.
- History of bone marrow transplantation.
- Diagnosed clinically significant autoimmune disease
- Wound that extends across the fingers, toes, pubic or perineum region are excluded from being index wounds.
- The subject has clinical evidence of an active infection at the wound site.
- Current malignancy (including skin cancer), a life expectancy of \< 2 years, or severe cardiopulmonary disease that restricts ambulation to the clinical facility.
- History of coagulopathy.
- Chronic use of systemic steroids or immunosuppressive agents.
- Allergy to human albumin, streptomycin, or penicillin.
- The subject is likely to be a recipient of tissue or organ transplantation.
- Current history of alcohol or substance abuse or has a history of alcohol or substance abuse that required treatment within the previous 12 months.
- History of poor compliance or unreliability.
- Females who are pregnant, nursing, or planning a pregnancy during their participation in the study.
- Concurrent participation in another investigational drug, biologic or device study that could confound study data.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.