Ongoing Clinical Trials for Hypertrophic Scar
Currently, there is 1 ongoing clinical trial investigating new treatments for hypertrophic scar. This trial is exploring the use of stem cell-based therapies to improve scar quality in patients with burn-related scarring. Hypertrophic scars are raised, thickened areas of skin that form when the body produces excess collagen during healing. Unlike keloids, they do not grow beyond the original wound boundaries but can be itchy, painful, and cosmetically concerning.
Clinical trial locations
Study on Improving Burn Scars with Adipose-Derived Stem Cells and Autologous Stromal Vascular Fraction for Patients with Hypertrophic Scarring
This clinical trial is investigating whether stem cell-based treatments can improve the quality of thick, raised scars that develop after burn injuries. The study is being conducted in Denmark and focuses on two experimental approaches: using adipose-derived stem cells (special cells taken from fat tissue) and autologous stromal vascular fraction (a mixture of healing cells from a patient’s own fat tissue).
Main inclusion criteria:
- Adults aged 18 years or older
- Thick, raised scars from burn injuries that are more than 2 years old, located on the front of the body or limbs
- Three similar areas of burn scar tissue, each measuring 6 cm x 6 cm, on the front of the chest or limbs, with at least two centimeters between areas
- BMI greater than 22 with enough abdominal fat for a small liposuction procedure
- Ability to understand information about the study
Main exclusion criteria:
- Participants who fall outside the specified age range
- Individuals who belong to vulnerable populations requiring special protection or care
- Certain gender-specific conditions may also exclude participants
Focus and goal of the trial:
The study aims to determine whether injections of stem cells or stromal vascular fraction can improve scar appearance and quality compared to a placebo treatment. Participants will receive injections directly into their scar tissue, and researchers will carefully monitor changes in scar volume, thickness, and appearance over time using photography, ultrasound, and tissue biopsies. Safety will be closely monitored throughout the trial, with documentation of any side effects.
The trial follows a structured timeline:
- Initial visit: Participants provide informed consent and confirm eligibility based on age, scar characteristics, and overall health.
- Baseline assessment: Current scar condition is evaluated through measurements, photography, ultrasound, and a small tissue biopsy.
- Treatment administration: Participants receive injections of the study treatment into the scar tissue.
- Follow-up visits: Regular monitoring includes repeat assessments and checks for any adverse effects.
- Final assessment: End-of-study evaluation measures changes in scar condition, with results discussed and follow-up care provided.
Investigational drugs being tested:
- Allogeneic Adipose-derived Stem Cells: Special cells taken from donor fat tissue that can develop into different cell types and promote healing. These cells work by enhancing tissue regeneration and reducing inflammation to help remodel scar tissue.
- Autologous Stromal Vascular Fraction: A mixture of cells taken from the patient’s own fat tissue, containing stem cells and other healing cells that support the body’s natural repair processes.
Both treatments are administered through direct injection into the affected scar area and are classified under regenerative medicine due to their ability to aid in tissue repair and regeneration.
Summary
Currently, only one clinical trial is actively recruiting patients with hypertrophic scarring from burn injuries. This trial, located in Denmark, represents an innovative approach to scar treatment by exploring stem cell-based therapies. The study specifically targets patients with mature burn scars that are at least 2 years old and focuses on comparing two different cell-based treatments against a placebo. This research may provide valuable insights into whether regenerative medicine approaches can offer better outcomes for individuals living with the physical and cosmetic challenges of hypertrophic scarring. Patients interested in participating should note the specific requirements regarding scar location, size, and body composition, as well as the need for adequate abdominal fat tissue for the procedure.
