In short
Clinical trials are investigating Adrc001 in different patient groups, including head and neck cancer survivors with dry mouth, people with perianal fistulas, and patients with hypertrophic scars after burns. These studies are looking at treatment effects, safety, and healing outcomes in Phase 1, Phase 1/2, and Phase 2 trials.
Key points
- Clinical trials of Adrc001 are studying three different conditions: dry mouth after radiotherapy in head and neck cancer survivors, complex perianal fistulas, and hypertrophic scars after burn injury. The studies include Phase 1, Phase 1/2, and Phase 2 designs. Researchers are measuring saliva flow, fistula healing, and scar score changes. All listed trials are authorised and use patient groups with specific conditions. The data focus on whether Adrc001 may improve symptoms or healing compared with control treatment.
Trial overview
The available studies of Adrc001 are all interventional studies, which means researchers give a treatment and then compare results with a control group or another treatment. The trials are authorised and cover three different medical problems: dry mouth after radiotherapy, crypto-glandular perianal fistula, and hypertrophic scarring.
Radiation-related dry mouth study
One Phase 2 trial is studying people with xerostomia, which means dry mouth, caused by radiotherapy for head and neck cancer. The study plans to include 100 participants and compares repeated intraglandular injections of Adrc001 with sterile isotone saline water, which is the placebo control in this trial.
The main goal is to see whether Adrc001 improves unstimulated whole salivary flow rate, which is the amount of saliva made without chewing or other stimulation. Researchers will measure this at baseline, 4 months, and 8 months, and the main comparison is the difference between groups after 8 months.
Perianal fistula study
A second study is a Phase 1/2 trial in 75 people with crypto-glandular perianal fistula, which is an abnormal tunnel near the anus. The study tests Adrc001 as an injectable treatment together with minimal surgical debridement, meaning the surgeon removes only the damaged or infected tissue needed for treatment.
This trial also includes other treatments in the study plan, such as metronidazole tablets and Zinnat tablets, but the key research question is whether the regenerative cell therapy approach helps the fistula heal. The study is looking at healing after 6 and 12 months.
Scar remodeling study
The third study is a Phase 1 trial in 39 participants with hypertrophic scarring, which means thick, raised scars. In this study, Adrc001 is given by intradermal injection, meaning an injection into the skin.
The trial is designed to look at the possible effect of Adrc001 on scar quality compared with placebo. The source data say the main measurement is the change in the total patient score of the Danish Patient and Observer Scar Assessment Scale version 3.0, which is a scar rating tool used to track how a scar looks and feels.
Main outcomes and what they mean
Each trial uses a different primary outcome, which is the main result the researchers want to measure. In the dry mouth study, the outcome is saliva flow measured by sialometry, a test that measures how much saliva is produced.
In the perianal fistula study, the main outcome is the healing rate after 6 and 12 months, and clinical healing means the external opening closes and there is no discharge or swelling when the area is examined by touch. In the scar study, the main outcome is the change in the scar assessment score, which helps show whether the scar gets better or worse over time.
Trial phases and who may take part
The three studies show how Adrc001 is being tested in different stages of research: Phase 1, Phase 1/2, and Phase 2. In general, Phase 1 studies are early trials, Phase 1/2 studies combine early safety and first signs of benefit, and Phase 2 studies look more closely at whether the treatment helps a specific condition.
The target populations are different in each trial: head and neck cancer survivors with radiation-related dry mouth, people with complex perianal fistula, and patients with hypertrophic scars after burn injury. These studies are not general studies for all patients; they focus on people with the exact conditions listed in the trial records.