Product Development

Product Development

cell regen standards

The University of Utah’s Cell Therapy and Regenerative Medicine (CellReGen™) has a robust research and development program of cellular and acellular biological products for therapeutic and clinical applications. 

  • CellReGen™ develops, tests and manufactures its own in-house products and therapeutics
  • CellReGen™ has patents and intellectual property on its proprietary processes
  • CellReGen™ collaborates with the University of Utah, other University investigators and industry partners on novel products and therapies

Amniotic Fluid Allograft

Amniotic Fluid Allograft is donated through informed consent by mothers having Caesarean Section deliveries.  The donor mother is tested for infectious diseases and evaluated for donor eligibility as outlined in 21 CFR 1271.

Acellular Amniotic Fluid (AFF) has been researched, developed and characterized by the University of Utah’s CellReGen™ program (1,2).  Prior to 2021, AFF was regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and used clinically since 2015 for a variety of clinical treatments including burns, wounds, etc.  There have been no adverse events reported with over 10,000 clinical applications.

Now regulated as a biologic, AFF is currently being tested in eight FDA-IND clinical trials, including but not limited to chronic wounds, osteoarthritis and low-radicular back pain.  Future clinical trials are being planned for ocular Epidermolysis Bullosa, COPD and other inflammatory conditions.  

  1. Pierce J, Jacobson P, Reems J, et al. Collection and characterization of amniotic fluid from scheduled C-section deliveries, Cell and Tissue Banking, International Journal for Banking, Engineering and Transplantation of Cells and Tissues Incorporating Advances in Tissue Banking, 2016; Vol. 17, No. 2, 2016.
  2. Moa Y, Pierce J, Reems J, et al. Processed human amniotic fluid retains its antibacterial activity, Journal of Translational Medicine, 2019, 17:68.

Amnion Membrane Allograft

Amnion Membrane Allograft (AM) is donated through informed consent by mothers having Caesarean Section deliveries.  The donor mother is tested for infectious diseases and evaluated for donor eligibility as outlined in 21 CFR 1271. 

AM has been researched and developed for clinical applications by the University of Utah’s CellReGen™ program.  AM is regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and used clinically since 2015 for a variety of clinical treatments including burns, wounds (3,4) nerve decompression, tendon repairs, etc.

  1. Frech TM, Lewis G, et al. Amniotic membrane dressings: an effective therapy for SSC-related wounds Rheumatology (Oxford), 2019, 58(4).

 

  1. Frigerio A, Pierce J, Reems J, et al. Amnion membrane allografts in a critically ill infant with Netherton syndrome-like phenotype, JAAD Case Rep., 2019 May; 5(5).

Platelet Lysate Serum Cell Culture Media Supplement

Platelet lysate Serum cell culture media supplement (PLS) is made from expired human donor plasma.  Plasma donors are tested for infectious diseases and donor eligibility.

PLS has been researched, characterized and developed by the University of Utah’s CellReGen™ program (5).   PLS has been used as a substitute for fetal bovine serum in cell culture expansion both for research and clinical grade cellular products.

  1. Mojica-Henshaw, M., Pierce J, et al. Serum-converted Platelet Lysate can Substitute for Fetal Bovine serum in Human Mesenchymal Stromal Cell Cultures, Cytotherapy, 2013;15:1458-1468.