In short
Clinical trials of HUMAN FIBROBLASTS are studying a topical treatment for chronic refractory wounds. The trial data focus on safety, tolerability, and signs of wound healing in adults with hard-to-heal ulcers. Researchers are also looking for the best dose and whether the treatment helps wounds improve or heal.
Key points
- Clinical trials of HUMAN FIBROBLASTS are studying a topical treatment for refractory wounds, which are wounds that are hard to heal. The main trial is a Phase 1/2 study with 52 participants. It first checks safety and tolerability with two different doses, then tests one chosen dose in an expansion part. The study also measures wound size, wound pain, wound bed score, healing time, and quality of life. The target group is people with chronic hard-to-heal wounds.
Trial overview
This article is about one clinical trial of HUMAN FIBROBLASTS for refractory wounds, which are wounds that are hard to heal. The study is interventional, which means the researchers give a study treatment and then watch what happens.
The trial is authorised and plans to include 52 people. It uses topical use, meaning the treatment is applied on the skin or wound area rather than taken by mouth.
Study design and phases
This is a Phase 1/2 study. Phase 1 studies usually focus on safety first, while Phase 2 studies look more closely at whether the treatment may help.
The study has two parts. In the first part, the team uses an open-label, dose escalation design to test two different doses and find the best dose for the next part. In the second part, the selected dose is tested further to assess efficacy, which means how well it works, and to confirm safety and tolerability.
Open-label means the study is not blinded, so the participants and investigators know what is being used. Dose escalation means the study checks more than one strength in steps before choosing the best one.
Who can participate
The trial is designed for people with chronic refractory wounds. The source data do not give more detailed entry rules, such as age limits or other medical requirements.
Because the study focuses on wounds that do not heal easily, it is meant for patients who have a long-lasting wound problem and need new treatment options.
What is being measured
The main safety measures include Treatment Emergent Adverse Events, also called TEAEs, which are problems that happen after the product is applied. The study also checks changes in physical examination findings, vital signs, 12-lead ECG, blood tests, and urine tests.
Another safety measure is the investigator’s overall tolerability score on a 5-point Likert scale, which is a simple rating scale from very well tolerated to not tolerated at all.
The efficacy measures focus on wound healing and symptom relief. These include change in ulcer size, change in wound area in square centimeters, change in the Wound Bed Score, and change in wound pain using a Visual Analogue Scale or VAS, which is a pain rating scale.
The study also measures the number of responders, meaning people whose ulcer area is reduced by at least 50%, the time to 50% wound reduction, the time to healing if healing happens, and changes in the Wound-QoL-14 questionnaire, which looks at quality of life related to the wound.
How results are judged
The wound size outcome is scored in six categories, from unchanged to fully healed. This helps the researchers see not only whether a wound gets smaller, but also whether it closes completely.
The study also looks at the investigator’s satisfaction with the product’s efficacy using a 5-point Likert scale, which helps show how the treatment performs in real clinical use. Together, these results are meant to give a full picture of safety, healing progress, pain, and patient impact.
Why this study matters
People with refractory wounds often need new options because their wounds are slow to improve. This trial is important because it first tries to find the best dose and then checks whether the chosen dose may help wounds heal better.
The study is focused on practical outcomes that matter to patients, such as wound size, pain, healing time, and quality of life. That makes it a patient-centered trial, with both safety and everyday wound improvement in view.