Regeneus, Cryosite to jointly manufacture human stem cell products

Under the terms of agreement, Regeneus will provide technology, know-how and research facilities to aid Cryosite in the development of methods for the expansion of cord tissue-derived mesenchymal stem cells (MSCs).

In turn, Cryosite will provide production facilities for Regeneus’ off-the-shelf allogeneic stem cell product for human osteoarthritis (OA), called Progenza.

Manufactured within Cryosite’s good manufacturing practice (GMP) clean room facilities by Regeneus staff, the product i scheduled to be used for clinical trial purposes.

Regeneus CEO professor Graham Vesey said: "This agreement allows Regeneus to cost effectively fast-track the production of Regeneus’ off-the shelf Progenza product for preclinical and clinical trials for market entry into Japan.

"Cryosite’s capabilities in the manufacturing and storage of GMP cell-based products in a TGA licensed facility complements Regeneus’ product development and early stage commercialisation capabilities.

"We foresee a future where our two companies use these capabilities together to develop and supply a range of regenerative medicine products."

Cryosite acting CEO Graeme Moore said: "The agreement has a direct and immediate effect on increasing Cryosite’s revenues and will enable the further development of a new cord tissue derived stem cell product that will complement our established cord blood stem cell banking service. Cord tissue contains MSCs that are not generally found in cord blood."

Progenza is Regeneus’ off-the-shelf stem cell product manufactured from a small amount of human donor’s fat for human OA.