Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05838092
Other study ID # allo-APZ2-EB-III-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 18, 2023
Est. completion date December 1, 2025

Study information

Verified date October 2023
Source RHEACELL GmbH & Co. KG
Contact Cristina Daniele
Phone +49 6221 71833-66
Email cristina.daniele@rheacell.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility Inclusion Criteria: 1. Male or female subjects from 6 months of age with a diagnosis of RDEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping 2. Subject is eligible to participate in this clinical trial based on general health condition; 3. Subject with a target wound meeting the following criteria: 5-50 cm2, = 21 days and < 9 months, no signs of acute infection; 4. Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure; 5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. Women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial. Exclusion Criteria: 1. Any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma; 2. Any known allergies to components of the IP or premedication; 3. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol; 4. Pregnant or lactating women; 5. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial; 6. Previous participation in this clinical trial (except for screening failures); 7. Clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; Confidential 8. Employees of the sponsor, or employees or relatives of the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
allo-APZ2-OTS
Allogeneic dermal ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs)
Placebo
Placebo

Locations

Country Name City State
United States Masonic Cancer Center and Medical Center Minneapolis Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
RHEACELL GmbH & Co. KG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects with complete target wound closure Proportion of subjects with complete healing of target wound, determined by the investigator, as compared to baseline 12 months
Secondary Time to complete target wound closure from baseline 12 months
See also
  Status Clinical Trial Phase
Completed NCT00380640 - The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa Phase 2
Completed NCT00004761 - Establishment of the National Epidermolysis Bullosa Registry N/A
Completed NCT01263379 - Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Completed NCT01716169 - Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care N/A
Withdrawn NCT01454687 - Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes N/A
Completed NCT00014729 - Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Phase 1
Recruiting NCT03269474 - Computational Drug Repurposing for All EBS Cases
Completed NCT03068780 - Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa Phase 3
Terminated NCT02090283 - Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 2
Completed NCT02582775 - MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Phase 2
Recruiting NCT04213703 - A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Completed NCT02384460 - ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 3
Terminated NCT02670330 - Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Phase 3
Terminated NCT01619670 - A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Phase 4
Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
Completed NCT02014376 - Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Phase 2
Completed NCT04217538 - Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
Completed NCT03942250 - Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients N/A
Completed NCT01033552 - Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs Phase 1/Phase 2
Completed NCT04227106 - Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 3