Study on Improving Burn Scars with Adipose-Derived Stem Cells and Autologous Stromal Vascular Fraction for Patients with Hypertrophic Scarring

1 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for hypertrophic scarring, which is a type of thick, raised scar that can develop after a burn injury. The study will explore the use of adipose-derived stem cells and autologous stromal vascular fraction to improve the quality of these scars. Adipose-derived stem cells are special cells taken from fat tissue, while autologous stromal vascular fraction involves using a patient’s own fat tissue to obtain cells that may help in healing.

The purpose of the study is to investigate whether these treatments can improve scar quality compared to a placebo. Participants will receive injections of either the stem cells, the stromal vascular fraction, or a placebo into their scar tissue. The study will monitor changes in the appearance and structure of the scars over time, using various methods to assess improvements.

Throughout the study, the safety of the treatments will be closely monitored, and any side effects will be documented. The trial aims to provide valuable insights into the potential benefits of using these cell-based therapies for treating hypertrophic scars, which could lead to better outcomes for individuals with burn injuries.

1 initial visit

Upon joining the study, you will attend an initial visit where the study team will explain the trial process. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

During this visit, your eligibility will be confirmed based on criteria such as age, scar characteristics, and overall health.

2 baseline assessment

A baseline assessment will be conducted to evaluate your current scar condition. This includes measurements of scar volume, thickness, and appearance using photography and ultrasound.

You will also undergo a biopsy, which involves taking a small sample of scar tissue for further analysis.

3 treatment administration

You will receive an injection of the study treatment into the scar tissue. The treatment involves the use of adipose-derived regenerative cells (ADRC001) or autologous stromal vascular fraction.

The injection is administered intradermally, meaning it is injected into the skin. The exact dosage and frequency will be determined by the study protocol.

4 follow-up visits

You will attend regular follow-up visits to monitor the effects of the treatment. These visits will include assessments similar to the baseline assessment, such as photography and ultrasound of the scar.

The study team will also monitor for any adverse effects or unexpected reactions to the treatment.

5 final assessment

At the end of the study period, a final assessment will be conducted to evaluate changes in your scar condition. This will include the same types of measurements and evaluations as previous assessments.

The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

Adults who are 18 years of age or older.
Have hypertrophic scars (thick, raised scars) that are more than 2 years old from burn injuries on the front of the body or limbs.
Have three similar areas of burn scar tissue, each measuring 6 cm x 6 cm, on the front of the chest or limbs. The scar should be large enough to have at least two centimeters between these areas.
Have a BMI (Body Mass Index) greater than 22 and enough abdominal fat for a small liposuction procedure.
Must be able to understand information about the project.

Who Cannot Join the Study?

Patients with hypertrophic scarring cannot participate. This means if you have thick, raised scars, you are not eligible.
Individuals who are not within the specified age range cannot participate. The study is open to certain age groups only.
Both male and female participants are eligible, but certain conditions may exclude you.
Participants who are part of a vulnerable population are not eligible. This refers to groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.01.2025

Trial locations

Investigated drugs:

Adrc001

Allogeneic Adipose-derived Stem Cells are special cells taken from the fat tissue of a donor. These cells have the ability to develop into different types of cells and help in healing and repairing damaged tissues. In this trial, they are being used to see if they can improve the quality of scars after a burn injury by promoting better healing and reducing scar tissue formation.

Autologous Stromal Vascular Fraction is a mixture of cells that is taken from a patient’s own fat tissue. This mixture contains various types of cells, including stem cells, which can help in tissue repair and healing. In this trial, the stromal vascular fraction is being used to see if it can improve the appearance and quality of scars after a burn injury by enhancing the body’s natural healing processes.

Investigated diseases:

Hypertrophic scar

Hypertrophic scar – Hypertrophic scars are raised, thickened areas of skin that form at the site of a wound. They occur when the body produces excess collagen during the healing process. These scars are often red or purple and can be itchy or painful. Unlike keloids, hypertrophic scars do not grow beyond the boundaries of the original wound. Over time, they may become less noticeable but can remain elevated. They are more common in areas of high skin tension, such as the shoulders and chest.

Trial ID:

2024-519160-41-00

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Improving Burn Scars with Adipose-Derived Stem Cells and Autologous Stromal Vascular Fraction for Patients with Hypertrophic Scarring

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?