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Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III)

Sponsored by RHEACELL GmbH & Co. KG

Quick Self-Assessment

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Current Status

Active, Not Recruiting

Auto-verified from ClinicalTrials.gov

Verified Oct 1, 2025

Phase

Clinical Trial

Sponsor

RHEACELL GmbH & Co. KG

Enrollment Target

250

Start Date

Dec 2024

๐Ÿ“Š
1 of 250 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.

Who Can Participate

Inclusion Criteria

Patients at least 18 years old; 2. Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index, physical examination and dermatological review; 3. Wound size at V1 and V2 between 1 and 25 cmห„2 as measured by standardized photography; 4. If patients have 2 or more ulcers at the same extremity, the target ulcer has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide; 5. Body mass index between 15 and 50 kg/mยฒ; 6. Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures; 7. Women of childbearing potential must have a negative urine pregnancy test at Visit 1; 8. During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

250 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

RHEACELL GmbH & Co. KG

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Hialeah

Florida

Location available
View Hialeah location page
Unknown

Miami

Florida

Location available
View Miami location page
Unknown

Boston

Massachusetts

Location available
View Boston location page
Unknown

Minneapolis

Minnesota

Location available
View Minneapolis location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

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Find More Interstitial Cystitis Trials by City

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Looking for Chronic Venous Ulcer Treatment in Hialeah?

Join others in Florida exploring innovative treatment options through clinical research

Chronic Venous Ulcer Treatment Options in Hialeah, Florida

If you're searching for Chronic Venous Ulcer treatment in Hialeah, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Hialeah, Miami, Boston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Chronic Venous Ulcer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 250 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Chronic Venous Ulcer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Chronic Venous Ulcer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Chronic Venous Ulcer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06489028. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.