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Adrc001

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.

Table of contents

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.[1][2][3] The trials are authorised and cover three different medical problems: dry mouth after radiotherapy, crypto-glandular perianal fistula, and hypertrophic scarring.[1][2][3]

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.[1] 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.[1]

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.[1] Researchers will measure this at baseline, 4 months, and 8 months, and the main comparison is the difference between groups after 8 months.[1]

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.[2] 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.[2]

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.[2] The study is looking at healing after 6 and 12 months.[2]

Scar remodeling study

The third study is a Phase 1 trial in 39 participants with hypertrophic scarring, which means thick, raised scars.[3] In this study, Adrc001 is given by intradermal injection, meaning an injection into the skin.[3]

The trial is designed to look at the possible effect of Adrc001 on scar quality compared with placebo.[3] 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.[3]

Main outcomes and what they mean

Each trial uses a different primary outcome, which is the main result the researchers want to measure.[1][2][3] In the dry mouth study, the outcome is saliva flow measured by sialometry, a test that measures how much saliva is produced.[1]

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.[2] 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.[3]

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.[1][2][3] 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.[1][2][3]

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.[1][2][3] These studies are not general studies for all patients; they focus on people with the exact conditions listed in the trial records.[1][2][3]

Trial IDPhaseCondition studiedStatusEnrollment
2025-522559-25-00Phase 2Xerostomia due to radiotherapy for head and neck cancerAuthorised100
2022-502659-73-01Phase 1/2Crypto-glandular perianal fistulaAuthorised75
2024-519160-41-00Phase 1Hypertrophic scarringAuthorised39

FAQ

  • What is Adrc001 being studied for in these trials? Adrc001 is being studied for radiation-related dry mouth, complex perianal fistulas, and hypertrophic scarring after burn injury. The trials are testing whether it can improve symptoms or healing compared with control treatment.
  • Who can take part in Adrc001 trials? The target groups are head and neck cancer survivors with xerostomia, people with crypto-glandular perianal fistula, and patients with hypertrophic scars. Each study has its own entry rules based on the condition being treated.
  • What trial phases are listed for Adrc001? The listed studies include Phase 1, Phase 1/2, and Phase 2 trials. Earlier phases usually look at safety and early signs of benefit, while Phase 2 studies focus more on whether the treatment works.
  • What outcomes are researchers measuring? One study measures salivary flow, another measures fistula healing, and another measures scar score changes. These are the main ways the trials check if Adrc001 helps.
  • Are these studies already running? All three trials are marked as authorised. That means they have approval to proceed, but the data provided do not show final results yet.

Ongoing Clinical Trials on Adrc001

  • Study on Treating Perianal Fistulas Using Adipose Derived Regenerative Cells, Metronidazole, and Cefuroxime for Patients with Complex Perianal Fistulas

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of ADRC001 (Adipose-Derived Stem Cells) for treating dry mouth (xerostomia) in patients who received radiation therapy for head and neck cancer

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Denmark

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

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Authorised: The study has received approval to start or continue.
  • Phase 1: An early trial phase that mainly checks safety and gives first signs of whether a treatment may help.
  • Phase 1/2: A study that combines early safety testing with a first look at how well the treatment works.
  • Phase 2: A trial phase that looks more closely at whether a treatment works in a specific condition.
  • Interventional study: A study where people receive a treatment or control so researchers can compare outcomes.
  • Xerostomia: Dry mouth, often caused here by radiotherapy.
  • Radiation-induced hyposalivation: Reduced saliva production caused by radiation treatment.
  • Perianal fistula: An abnormal tunnel near the anus that can cause drainage and swelling.
  • Hypertrophic scarring: A thick, raised scar that forms after injury such as a burn.
  • Primary outcome: The main result the researchers plan to measure.
  • Unstimulated whole salivary flow rate: The amount of saliva made without chewing or other stimulation.
  • Sialometry: A test that measures saliva flow.

References

  1. https://clinicaltrials.gov/study/2025-522559-25-00
  2. https://clinicaltrials.gov/study/2022-502659-73-01
  3. https://clinicaltrials.gov/study/2024-519160-41-00