The company's allogeneic stem cell technology platform for the treatment of osteoarthritis (OA) and other inflammatory conditions is called Progenza. Results of the phase 1 STEP trial (Safety, Tolerability and Efficacy of Progenza) were published in the Journal of Translational Medicine in 2018.
The study showed that a single injection of Progenza, which are cells, into the knee was safe and well tolerated by patients the treatment was shown to have durable and clinically meaningful pain relief in patients with knee OA. A statistically significant improvement in lateral tibial cartilage volume for patients treated with 3.9 million cells of Progenza was shown by MRI compared to a worsening of the condition in placebo patients (p=0.028).
Progenza is an allogeneic off-the-shelf stem cell technology platform developed for the treatment of knee osteoarthritis and other inflammatory conditions. Progenza cells reduce inflammation and pain and encourage accelerated healing and repair through secretion of cytokines, growth factors and exosomes.
Progenza is produced from expanded mesenchymal stem cells (MSCs) extracted from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from MSCs that improve viability and functionality of the cells during the freezing and thawing process. Regeneus has shown that a combination of cells and secretions has a more powerful therapeutic effect than cells alone.
Progenza is manufactured using adipose-derived MSCs and are expanded through the company's proprietary and scalable manufacturing process which has the capacity to produce millions of therapeutic doses of Progenza from a single donor.
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