Is NCT04173650 recruiting in Philadelphia, PA?

Yes, NCT04173650 is currently recruiting participants at its Philadelphia, PA location. This epidermolysis bullosa clinical trial is actively enrolling qualified participants.

How do I join the epidermolysis bullosa clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Epidermolysis Bullosa Clinical Trial in Philadelphia, PA

About This Epidermolysis Bullosa Study in Philadelphia

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). STUDY DESIGN: This is a phase 1/2A, randomized, multi-center, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.

Sponsor: Aegle Therapeutics

Who Can Participate

Inclusion Criteria

Subjects must be 6 months or older at screening.

Subjects who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. Subjects with severe DEB (e.g., RDEB patients with absent Col VII/no anchoring fibrils) and milder forms of DEB (e.g., RDEB patients with reduced Col VII and/or anchoring fibril levels) are eligible.

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 matched pair. Neither index wound may have been treated with any local (topical, subcutaneous, etc) or systemic therapeutic other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required) in the past 3 months prior to screening.

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 of birth control include oral, implant, injectable, and transdermal contraceptives; an intrauterine device; or other forms considered acceptable by the investigator. A female subject is eligible to participate if she is not pregnant, is not a woman or childbearing potential (WOCBP), or is a WOCBP who agrees to follow the contraceptive guidance above.

Post-pubertal males who agree to use an acceptable method of contraception for the duration of the study.

Subjects 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. Subjects under the age of 18 years must be capable of giving assent (if age-appropriate), and/or they must have a guardian capable of providing consent.

Willing to comply with the protocol requirements. Note: Reference to Appendix 3 can be located in the protocol

Exclusion Criteria

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 protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required). Concomitant treatment of non-study wounds with local therapy during the study is acceptable. Systemic treatment of RDEB wounds (except as noted for standard of care) during the study is not acceptable. Subjects unwilling to abstain from prohibited concomitant treatment of study wounds (treated or control) and/or systemic treatment of RDEB wounds during the study period are excluded.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT04173650) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Epidermolysis Bullosa Treatment Options in Philadelphia, PA

If you're searching for epidermolysis bullosa treatment options in Philadelphia, PA, this clinical trial (NCT04173650) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced epidermolysis bullosa specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all epidermolysis bullosa clinical trials near you to find additional studies recruiting in your area.

Epidermolysis Bullosa Clinical Trial in Philadelphia, PA

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