ASC Therapy / Rigshospitalet - LARVOL DELTA

Exploring the salivary proteome following intraglandular mesenchymal stromal cell therapy for radiation-induced hyposalivation in previous head and neck cancer patients: a secondary study protocol for the MESRIX-III, randomised, controlled trial. (PubMed, Trials) - P2 | "This study will gain insights into the potential mode of action of intraglandular ASC therapy for radiation-induced hyposalivation. The results may open avenues for a clinically applicable and disease-modifying treatment to ameliorate hyposalivation and restore salivary gland function following radiation therapy in previous head and neck cancer patients. Moreover, it will constitute the most extensive collection of data characterising the salivary proteome post-radiation therapy in the head and neck region."

Clinical protocol • Journal • Dental Disorders • Head and Neck Cancer • Oncology • Solid Tumor • Transplantation • Xerostomia

Mesenchymal Stem/Stromal Cell Therapy for Radiation-Induced Xerostomia in Previous Head and Neck Cancer Patients: A Phase 2 Randomised, Placebo-Controlled Trial. (PubMed, Clin Cancer Res) - "We could not confirm superiority of the ASC relative to placebo. ASC therapy significantly improved UWS in previous head and neck cancer patients, whereas placebo resulted in an insignificant increase."

Journal • P2 data • Stroma • Dental Disorders • Head and Neck Cancer • Oncology • Solid Tumor • Xerostomia

Effect of allogeneic adipose tissue derived mesenchymal stromal cell treatment in chronic ischemic heart failure with reduced ejection fraction - The SCIENCE Trial. (PubMed, Eur J Heart Fail) - "The SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the predefined endpoints and induce restoration of cardiac function or clinical symptoms."

Journal • Review • Stroma • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure

Long-Term Safety of Treatment with Autologous Mesenchymal Stem Cells in Patients with Radiation-Induced Xerostomia: Primary Results of the MESRIX Phase 1/2 Randomized Trial. (PubMed, Clin Cancer Res) - "Our data show that ASC therapy is safe with a clinically relevant effect on xerostomia-related symptoms. Confirmation in larger randomized controlled trials is warranted."

Journal • P1/2 data • Dental Disorders • Oncology • Oropharyngeal Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Xerostomia

ASC COVID-19: ASC Therapy for Patients With Severe Respiratory COVID-19 (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: Rigshospitalet, Denmark; N=40 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8 • CRP

ASC COVID-19: ASC Therapy for Patients With Severe Respiratory COVID-19 (clinicaltrials.gov) - P1/2; N=40; Not yet recruiting; Sponsor: Rigshospitalet, Denmark

Clinical • New P1/2 trial