A multi-synergistic therapy

Progenza™ is a cellular therapy targeting pain and inflammation which uses Secretome to improve not only the resident tissue, but the Mesenchymal Signalling Cells (MSCs) themselves. Using the Secretome with the MSCs provides a platform to enhance the MSCs’ potency and efficacy as a cryopreserved injectable.

Regeneus has patented techniques and high-quality testing to ensure the production of millions of Progenza™ doses from a single donor (allogeneic).

Point of Difference

Progenza™ fills a gap in the current treatment market for osteoarthritis by providing disease modification and pain relief to address patient symptoms – before more drastic treatments such as surgery, are required.

Currently, there are no treatments for osteoarthritis when it comes to disease modification. While there are many options for pain relief for osteoarthritis – including opioid drugs – they only treat the symptoms, not the cause of pain. Many pain relief treatments are also associated with addiction and dependence.

View the Phase I Trial Results for Progenza™

Mechanism of Action

MSCs are immune evasive, meaning they lack immune system identifiers. This allows them to enter a patient’s body and immune system relatively undetected.

When MSCs enter the inflamed environment within a patient’s body, they are activated and alter the phenotype of inflammatory immune cells. This switches the cells into anti-inflammatory, thereby addressing inflammation at its source.

Once at the site of injury, Progenza™ interacts with inflammatory immune cells and downregulates pain-causing signals. Progenza™ also acts to repair local damaged tissue, such as cartilage tissue commonly found in joints like knees and elbows.

Cells secreting Cytokines

Research & Scientific Publications

A selected list of scientific publications related to Progenza™ and Mesenchymal Signalling Cells (MSC) and their Secretome.

Protein synthesis and secretion in human mesenchymal cells derived from bone marrow, adipose tissue and Wharton’s jelly

Amable PR, Teixeira MVT, Carias RBV, Granjeiro JM, Borojevic R.
Stem Cell Res Ther. BioMed Central; 2014;5: 53. doi:10.1186/scrt442

Minimal criteria for defining multipotent mesenchymal stromal cells

Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, et al.
The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8: 315–317. doi:10.1080/14653240600855905

Role of Mesenchymal Stromal Cells as Therapeutic Agents: Potential Mechanisms of Action and Implications in Their Clinical Use

Jimenez-Puerta GJ, Marchal JA, López-Ruiz E, Gálvez-Martín P.
J Clin Med. MDPI AG; 2020;9: 445. doi:10.3390/jcm9020445

Immunoregulation by Mesenchymal Stem Cells: Biological Aspects and Clinical Applications

Castro-Manrreza ME, Montesinos JJ.
doi:10.1155/2015/394917

Adipose mesenchymal stem cells protect chondrocytes from degeneration associated with osteoarthritis

Maumus M, Manferdini C, Toupet K, Peyrafitte JA, Ferreira R, Facchini A, et al.
Stem Cell Res. Elsevier B.V.; 2013;11: 834–844. doi:10.1016/j.scr.2013.05.008

Mechanisms of T-cell immunosuppression by mesenchymal stromal cells: What do we know so far?

Haddad R, Saldanha-Araujo F.
BioMed Research International. 2014. doi:10.1155/2014/216806

T Cells in Osteoarthritis: Alterations and Beyond

Zhong J, Chen C, Yue X, Lei G-H, Li Y-S, Zhu LW, et al.
Front Immunol. 2017;8. doi:10.3389/fimmu.2017.00356

Mesenchymal stem cells secrete factors that inhibit inflammatory processes in short-term osteoarthritic synovium and cartilage explant culture

van Buul GM, Villafuertes E, Bos PK, Waarsing JH, Kops N, Narcisi R, et al.
Osteoarthr Cartil. W.B. Saunders; 2012;20: 1186–1196. doi:10.1016/J.JOCA.2012.06.003

Secretion of immunoregulatory cytokines by mesenchymal stem cells

Kyurkchiev D.
World J Stem Cells. 2014;6: 552. doi:10.4252/wjsc.v6.i5.552

Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: A randomized double-blind placebo-controlled single ascending dose study

Kuah D, Sivell S, Longworth T, James K, Guermazi A, Cicuttini F, et al.
J Transl Med. BioMed Central; 2018;16: 1–13. doi:10.1186/s12967-018-1420-z

Large-scale production of stem cells utilizing microcarriers: A biomaterials engineering perspective from academic research to commercialized products

Tavassoli H, Alhosseini SN, Tay A, Chan PPY, Kah S, Oh W, et al.
Biomaterials. 2018;181: 333–346. doi:10.1016/j.biomaterials.2018.07.016

Early Transplantation of Mesenchymal Stem Cells After Spinal Cord Injury Relieves Pain Hypersensitivity Through Suppression of Pain-Related Signaling Cascades and Reduced Inflammatory Cell Recruitment

Watanabe, S., Uchida, K., Nakajima, H., Matsuo, H., Sugita, D., Yoshida, A., . . . Baba, H. (2015).
STEM CELLS, 33(6), 1902-1914. doi:10.1002/stem.2006

Intrathecal administration of mesenchymal stem cells reduces the reactive oxygen species and pain behavior in neuropathic rats

Zhang, E. J., Song, C. H., Ko, Y. K., & Lee, W. H. (2014).
Korean J Pain, 27(3), 239-245. doi:10.3344/kjp.2014.27.3.23

Progenza™ in Action

Progenza™ has completed Phase I clinical studies for knee osteoarthritis, and is in pre-clinical stage for neuropathic pain. Regeneus is currently seeking collaborative partnership opportunities to commence Phase I trial of Progenza™ in neuropathic pain.

Osteoarthritis (OA)

Osteoarthritis is often referred to the ‘wear and tear’ around the tissue of joints and is characterised by pain and inflammation.

As MSCs are particularly important in diseases like osteoarthritis as they can repair damaged tissue by activating stem cells within the tissue and replacing damaged cells.

A Phase I study of Progenza™ in OA patients (KL Grade 1-3) demonstrated significant treatment-related reductions in pain for up to 12 months, as well as stabilisation of cartilage volume in the target dose group.

Neuropathic Pain

Neuropathic pain is a pain condition generally caused by chronic, progressive nerve disease. A patient with neuropathic pain can experience pain unrelated to an event or injury – the body just sends pain signals to the brain unprompted.

Progenza™ may have potential in addressing neuropathic pain. Pre-clinical studies have shown that a single injection of Progenza™ resulted in the complete reversal of symptoms of allodynia, a condition in which pain occurs from what is normally non-painful stimulation of the skin, such as light touch.

See our Product Pipeline