Project Structure & Methodology

The cmRNAbone project was structured in three main pillars aiming to:

  1. create new insights and solutions in the field of regenerative medicine (WP1–4),
  2. provide sound scientific assessment of the regenerative capacity of the proposed therapy (WP5–7), and
  3. develop regenerative application via preclinical proof of concepts and advance towards a regulatory and commercial path for a first in-human trial (WP8).

Thus, the following work packages were defined:

For more information, please click on the graphic below

image/svg+xmlcmRNAs in vitro transcription, purification, characterization, inducibility in Std assays GMP-likeVector formulationsproduction & characterization, inducibility improvement in Std assays, cytocomp., inducibilty in GAM. GMP-likefHA and CaP synthesis and characterization, fHA/CaP formulation optimization of visco-eleastic properties, cmRNA/vector loading/release, cells viability & ingrowth, GMP-likeExtrusion optimization of WP3 formulation and 3D printing parameters, design of device and fabrication of prototypesIn vitro assessements of single and combination of cmRNAs - Dose response.Mesenchymal stromal cells, osteoblasts, endothelial cells – hMSCs on top cmRNAs/vectors fHA-CaP -> induced protein released in media -> effect on cells (SNs, Ecs, hMSCs, pericytes, Osteo.); in vivo ectopic assessement of single cmRNAs High/Medium/Low dose -subcut. Nude mice, 8 weeks, characterized by histology, CTCombination of cmRNAs-vectors fHA-CaP in vivo proof of concepts.1. Critical bine size defect model. 8 weeks, CT, MRI, histology2. Bone defect in osteoporotic model, 8 weeks, CT, Biomeca., Gene Exp., histologyfHA-caPWP 1WP 3WP 4WP 2WP 5–7WP 8SEMA3AVEGF/PDGF-bbBMP-7