Clinical trials:In collaboration with other clinicians at Odense University Hospital, we are conducting four clinical trials using autologous (i.e. the patients own) freshly isolated adipose derived regenerative (stem) cells (ADRCs) for treatment of various diseases:
• Erectile Dysfunction following Radical Prostatectomy. Placebo-controlled, double-blinded Phase 2 RCT with 70 patients (EDCorrect).
• Breast Cancer Related Lymphedema. Placebo-controlled, double-blinded Phase 2 RCT with 126 patients (LymphREG).
• Chronic Wound. Phase 1/2 RCT with 30 patients.
• Perianal Fistulas in Crohn’s disease. Phase 1 pilot study with 20 patients
We have ongoing projects addressing very basic biological questions as well as translational studies and preclinical trials. Our overall goal is to optimize ADRC isolation, provide a comprehensive characterization of the ADRCs and link this to the clinical response:
• ADRC isolation is optimized using novel enzymes and equipment. Collaboration with Novozymes.
• In vitro cell models are used to identify pathways that are affected in lymphangiogenic or angiogenic cells.
• Pre-clinical models for lymphedema (mouse, in-house validated) are utilized to test the ability of different FACS sorted mouse ADRCs to restore lymphatic drainage.
• Single-cell RNAseq of ADRC subpopulations provides us with novel insight into the underlying cellular and molecular mechanism of ADRC action.