Clinical research trials (companion dogs)
✓
In these studies, we enrolled 58 client-owned companion dogs diagnosed with osteoarthritis affecting joints, including the elbow, hip, knee, ankle, and hock. Dogs were treated with allogeneic mesenchymal stem cells (MSCs) sourced from visceral adipose tissue collected as surgical material during routine ovariectomy procedures. The primary endpoint was improvement in lameness, evaluated by owners' subjective observations over 12 months, followed up after 4–5 years. Clinical safety was assessed by monitoring for injection-site adverse reactions and the incidence of tumours or other disease events following treatment. Results showed that 83% of dogs improved or retained improvement in lameness across the extended follow-up period. Only two cases of brief local inflammation at the injection site, each lasting less than one week, were reported, with no serious adverse effects observed. This study has been published in a peer-reviewed journal.
In vivo proof of concept I (laboratory)
✓
Laboratory studies were used to identify the effective dose of ADStem for future studies. This study laid the foundation for further development of ADStem.
Target animal safety (laboratory)
✓
A target animal safety study is a controlled laboratory study designed to evaluate the safety of ADStem before progressing to larger-scale clinical trials. These studies assessed adverse reactions, tolerability, and dosing thresholds in dogs, providing critical safety data to support ADStem's advancement through the regulatory process.
In vivo proof of concept II (companion dogs)
✓
Studies were conducted in client-owned companion dogs to further evaluate the ability of ADStem to impact lameness and clinical signs of joint pain, as measured by a combination of owner assessment, clinical examinations, and weight-bearing of the treated joint. These studies confirmed earlier laboratory findings in a real-world setting and provided further evidence supporting the progression of ADStem through the regulatory process.
CMC Scalable GMP production
✓
Chemistry, Manufacturing, and Controls (CMC) work was undertaken to establish a scalable, Good Manufacturing Practice (GMP)-compliant production process for ADStem. This included optimising our cell isolation, product formulation, and the strictest set of quality control processes to ensure consistent product quality, purity, and potency across batches. Scalable GMP production is a critical regulatory requirement that ensures ADStem can be manufactured reliably at the volumes required for regulatory clinical trials and future commercial use.
Dose finding study (companion dogs)
✓
The therapeutically effective dose of ADStem has been evaluated in dogs with OA in a placebo-controlled, regulatory-compliant clinical trial. The study confirmed that ADStem is highly effective in treating OA-related lameness and pain, and demonstrated very good safety.
Combined results from the above work and various studies enabled us to design our final, pivotal trial, in which the safety and effectiveness of ADStem are confirmed against placebo-treated dogs.
Dose confirmation study (companion dogs)
✓
The dose confirmation study has now been completed in client-owned companion dogs. This study verified the optimal dose of ADStem identified in earlier studies and evaluated lameness-associated pain over a 2-month period across three study sites. Its results confirm the dose to be used in clinical practice and contribute to the ongoing regulatory submission for ADStem.
EMA regulatory dossier
In progress
The European Medicines Agency (EMA) regulatory dossier for ADStem is currently in preparation. The EMA's authorisation process allows veterinary medicines to reach patients while meeting rigorous standards for safety, quality, and efficacy. ADStem addresses an important unmet need in lameness and pain due to osteoarthritis, and we are now compiling our scientific dossier, summarising our results and demonstrating proof of product safety, quality, and efficacy. This will be submitted to EMA, allowing us to make ADStem available to dogs who need it most as early as possible. To receive authorisation, the product must meet the same stringent safety and manufacturing standards required of all EMA-approved veterinary medicines.
Available in the global market
In progress
If ADStem receives regulatory authorisation from the EMA and other relevant global authorities, veterinarians will be able to prescribe ADStem to qualifying dogs.
