Welcome, Guest
Username: Password: Remember me
Adult Stem Cell News and Developments other than Cytori
  • Page:
  • 1

TOPIC: Regeneus Ltd (ASX:RGS) Receives Approval for Osteo

Regeneus Ltd (ASX:RGS) Receives Approval for Osteo 23 Apr 2015 08:02 #4333

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 889
  • Thank you received: 148
Fas, This Australian listed company claims millions of doses can be made from donor adipose MSCs. Not saying I believe it, just pointing it out...


Sydney, April 22, 2015 AEST (ABN Newswire) - Regeneus (ASX:RGS), a clinical stage regenerative medicine company focused on the development of cell therapies, announced today that it has received ethics approval for a clinical trial of its new off-the-shelf allogeneic stem cell treatment, known as Progenza, for patients with knee osteoarthritis.

Progenza is produced from adipose (fat) tissue from a healthy donor who has been extensively screened. The mesenchymal stem cells (MSCs) from adipose tissue are expanded through the company's proprietary and scalable manufacturing process that is capable of producing millions of therapeutic doses from one donor.

When Progenza stem cells are injected into a patient's osteoarthritic joint, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease.

The trial is entitled, "A Phase 1 randomised, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability and preliminary efficacy of intra-articular Progenza in adults with symptomatic knee osteoarthritis" (the STEP Trial). The approval clears the way for site initiation and patient recruitment into the STEP Trial.

Leading Sydney-based sports medicine specialist, Dr Donald Kuah, will be the principal investigator on the STEP Trial. Dr Kuah, a principal of Sydney Sportsmed Specialists, has extensive experience in the diagnosis and treatment of patients with osteoarthritis. He is also a pioneer in the testing and use of autologous adipose-derived stem cells and platelet rich plasma for the treatment of musculoskeletal conditions.

The STEP Trial will include 20 participants with knee osteoarthritis. Participants will receive ultrasound-guided injections of Progenza or placebo directly into their arthritic knee joint. The primary objective of the trial is to evaluate the safety and tolerability of Progenza. The secondary objectives are to investigate the effect of Progenza on knee pain and function; quality of life; knee joint structures using magnetic resonance imaging; and osteoarthritis biomarkers. Participants will be monitored for 12 months with an interim safety review at 1 month post treatment.

"I'm excited to be the principal investigator of the STEP Trial evaluating the safety and preliminary efficacy of Progenza for osteoarthritis. The clinical testing of an off-the-shelf allogeneic cell therapy like Progenza which could address the underlying cause of the disease is important for providing a new potential treatment option to patients with osteoarthritis", said Dr Kuah.

The STEP Trial was approved by an independent Human Research Ethics Committee registered with the Australian Government's National Health and Medical Research Council. The Trial will be registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) and notified to the Therapeutic Goods Administration through the Clinical Trials Notification Scheme.

Trial recruitment will commence as scheduled in the first-half of 2015.

About Progenza:

Progenza is an off-the shelf allogeneic stem cell product for the treatment of osteoarthritis. The product is produced from mesenchymal stem cells (MSCs) from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from donor MSCs that improves viability and functionality of the cells after freezing.

Adipose tissue is readily available from donors in large quantities and has significantly higher MSCs per gram of tissue than other tissue sources such as bone marrow or cord tissue. Also adipose-derived MSCs show greater capacity for expansion than MSCs from other tissue types that helps to increase the number of therapeutic doses from a single donor. The MSCs from adipose tissue are expanded through the company's proprietary and scalable manufacturing process. The company has demonstrated the capacity to produce from a single donor, millions of therapeutic doses of Progenza.

When Progenza cells are injected into the damaged joint or tissue, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease.
The following user(s) said Thank You: d9dozrman

Please Log in or Create an account to join the conversation.

Regeneus Ltd (ASX:RGS) Receives Approval for Osteo 23 Apr 2015 08:36 #4335

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

This Australian listed company claims millions of doses can be made from donor adipose MSCs. Not saying I believe it, just pointing it out...


I am sure they can do that- but the big question is, whether the cells will be potent or not. I doubt this.
Anyway- nice to see that they are doing knee OA too- at least one gets a reference point and possibility to compare outcomes. :grin:

For those interested in the issue- this is what Tigenix tells about their allo culture process ( of course adipose based too)

Tigenix has in common with Cytori that both Companies use the Sistemic QC package for FDA and EMA requirements.

TiGenix has developed its platform using expanded stem cells extracted from adipose tissue (eASCs), which are sourced from and applied to consenting patients. Therefore, and in contrast to cells of embryonic origin, there are no complex ethical issues associated with the use of eASCs. By using eASCs, TiGenix is also able to capitalize on the benefits associated with this type of cell compared to other cell types (i.e. bone marrow- derived stem cells). These advantages can be summarized as follows.
1. Advantages in cell obtention

Ease and amount of supply: Fat is a readily available tissue source collected through a simple liposuction that does not affect the patient’s health.
Rich supply of progenitor cells: Progenitor cells represent 2% of the total cells of the Stromal Vascular Fraction (“SVF”) of the fat tissue whereas the equivalent cell type on bone marrow only represents 0.002% of total cells. This translantes into a yield of 500 to 1,000 times more stem cells derived from adipose tissue when compared to a similar volume of bone marrow, thus implying a more abundant cell supply from a lower volume of tissue.
Robust phenotype: ASCs do not require overly elaborate growth conditions and can be grown continuously without loss of their primary characteristics.
Enhanced safety through well understood mechanism of action: The mechanism of action is based on the anti-inflammatory effect of the eASCs. It does not depend on cell differentiation, thereby reducing the risk of unforeseen cell type formation. This coincides with TiGenix’ work, which has found no tumorigenic behavior after long term ex vivo culture of eASCs.
2. Advantages in cell expansion

eASCs have a markedly higher proliferation rate and faster attachment than BM-MSC in-vitro cell culture
Higher stability: ASCs are less prone to senescence and differentiation
Differentiation capacity diminishes with expansion time without losing immunomodulatory properties
3. Superiority as therapeutic agent

Superior inflammation targeting capacities than BM-MSC

Higher safety: eASCs do not express ligands for NK receptors and thus are unlikely to elicit an immune rejection




The following user(s) said Thank You: d9dozrman

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Regeneus Ltd (ASX:RGS) Receives Approval for Osteo 23 Apr 2015 08:49 #4336

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 889
  • Thank you received: 148
I never understood the path taken by TiGenix. Autologous expanded cells from adipose. It doesn't get the advantages of off-the-shelf model and there would be little interest from big pharma. Doesn't get the advantage of fresh cells and a lower cost of goods like Cytori. An autologous therapy requiring expansion and multiple patient visits seems like the worse of the worse way to go,

Please Log in or Create an account to join the conversation.

Regeneus Ltd (ASX:RGS) Receives Approval for Osteo 23 Apr 2015 09:10 #4339

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

I never understood the path taken by TiGenix. Autologous expanded cells from adipose. It doesn't get the advantages of off-the-shelf model and there would be little interest from big pharma. Doesn't get the advantage of fresh cells and a lower cost of goods like Cytori. An autologous therapy requiring expansion and multiple patient visits seems like the worse of the worse way to go,


Yes- they wasted a lot of time and money by learning the hard way. The Spanish Company Cellerix (before they merged with Tigenix) already was conducting clinical trials in 2002 (fistula :winky: ) and abandoned autologous in 2008/9 or so. Quite a learning curve... :whistle:

Please Log in or Create an account to join the conversation.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
  • Page:
  • 1
Time to create page: 0.085 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites