Active not recruitingPHASE3INTERVENTIONAL

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

This study is testing a new cream called allo-APZ2-CVU for people with leg ulcers that haven't healed despite other treatments. These are often called chronic venous leg ulcers. The cream contains special cells taken from healthy donors. We want to find out if this new cream is effective at helping wounds heal and if it is safe to use. Some participants will receive the new cream, while others will receive a dummy cream (placebo). Neither you nor your doctor will know which treatment you are receiving until the study is over. We will monitor your wound healing, check how you feel, and look for any side effects over several months.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

RHEACELL GmbH & Co. KG

Enrolment target

250

Start

26 Dec 2024

Estimated completion

01 Sep 2027

Venous Leg Ulcer

What is this study about?

You're reading about a research study looking into a new possible treatment for leg ulcers that have been difficult to heal. These are often called chronic venous leg ulcers. These ulcers can be very uncomfortable and can last a long time, even with regular care. The new treatment being tested is a cream called allo-APZ2-CVU.

This special cream contains tiny living cells, which are taken from donors who have given their skin tissue – similar to how blood donations work. These cells are thought to help with the healing process. The main goal of this study is to see if this cream helps these stubborn leg ulcers heal better than usual, and to make sure it's safe for people to use.

To find out if the cream works, some people in the study will get the actual cream, and others will get a 'dummy' cream, also known as a placebo, which looks identical but doesn't contain the active cells. This is a common way to test new medicines fairly. We will compare how well the wounds heal in both groups.

Key takeaways

This study tests a new cream for hard-to-heal leg ulcers.
The cream uses special cells to encourage wound healing.
Some participants get the active cream, others get a dummy cream.
Your wound healing, pain, and quality of life will be monitored.
Participation involves regular visits over about 16 months.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a chronic venous leg ulcer on your lower leg or ankle that hasn't healed for a while, but not for more than 15 years. Your ulcer should be between 1 and 25 square centimetres in size. If you have more than one ulcer on the same leg, the one we focus on needs to be at least 1 centimetre away from the others.

There are also some reasons why you might not be able to join. For example, if your ulcer is very deep and affects muscle, tendon, or bone, or if you have uncontrolled diabetes. Also, if your wound has already started to shrink a lot by itself, or if you can't wear compression bandages, you might not be suitable. We also can't include people with recent blood clots in their legs or certain medical conditions, or those taking medications that affect wound healing. Women who could become pregnant must use effective contraception during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have a leg ulcer that hasn't healed, but has been there for less than 15 years?
Is your ulcer between 1 and 25 square centimetres in size?
Can you wear compression bandages on your leg?
Are you able to agree to take part in a study?
If you are a woman who could become pregnant, are you willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you decide to join, your journey will involve several visits over many months. At your first few visits, we'll check your ulcer, take pictures, and measure its size. You'll then receive the study cream (either the new treatment or the dummy cream) applied to your ulcer on day zero of your treatment. After that, we'll follow your progress for 18 weeks, with regular visits to see how your wound is healing, take more photos, and ask about your pain levels and overall quality of life.

Throughout the study, we'll keep a close eye on your safety. After the main 18-week treatment period, you'll have three more follow-up safety checks at 6, 10, and 16 months from when you started treatment. In total, your participation in the study from start to finish will last about 16 months.

Potential risks and benefits

You might get the new treatment which could help your ulcer heal, or you might get the dummy cream, which won't directly treat your ulcer but will still ensure you receive regular wound care. There's always a chance of side effects with any new treatment, but we will monitor you closely. We will also carefully check for any changes in your ulcer or general health. You can stop being part of the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

RHEACELL Clinical Trial Site
Verified postcode
Hialeah, United States
RHEACELL Clinical Trial Site
Verified postcode
Miami, United States
RHEACELL Clinical Trial Site
Verified postcode
Boston, United States
RHEACELL Clinical Trial Site
Verified postcode
Minneapolis, United States
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Austria
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Czechia
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, France
RHEACELL Clinical Trial Site
Unverified
Several Locations, Germany
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Hungary
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Italy
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Netherlands
RHEACELL Clinical Trial Site
Unverified
Multiple Locations, Poland

Common questions

What is a 'chronic venous leg ulcer'?

It's an open sore on your leg, usually around the ankle, caused by poor blood flow in your veins that has not healed for a long time.

What is 'allo-APZ2-CVU'?

It's the name of the new cream being tested. It contains special cells from healthy donors that are hoped to help with healing.

Will I know if I'm getting the real cream or the dummy cream?

No, neither you nor your study doctor will know until the study is over. This is to make sure the results are fair.

How often will I need to visit the clinic?

You'll have regular visits for about 18 weeks to check your wound healing, followed by three more safety visits over the next year.

What if my ulcer gets worse during the study?

Your doctors will be monitoring your ulcer closely. If it gets worse or any concerns arise, they will address it and you can leave the study at any time.