I recall that some yers ago, the potential offered for CLBP was one of the reasons for purchasing MSB as I also do suffer from CLBP.
Below are some of the announcements regarding CLBP:
1." In 2019 when Mesoblast signed a partnership agreement with Grunenthal, the following was the press statement dated 10 September 2019:
MPCs have generated great interest in clinical science and medicine due to their immunomodulatory effects and their role in tissue repair and regeneration.These cells have been shown to be effective in reducing inflammation and promoting the regeneration of host tissues through cell-to-cell interactions and secretion of a wide range of endogenous analgesic and anti-inflammatory molecules.
Furthermore, in degenerative disc disease, these cells could contribute to regenerating physiological disc tissue by promoting the proliferation of host chondrocytes and their secretion of tissue matrix components.Among key characteristics of MPCs are their capacity for significant expansion in culture and their relative lack of immunogenicity. These properties facilitate their use as allogeneic, or “off-the- shelf”, therapeutics with well-defined release criteria and batch-to-batch reproducibility that meet stringent regulatory requirements.
If clinical trial results from Phase II are confirmed, MPC-06-ID could offer a new treatment option to patients otherwise considered unresponsive to conservative therapy, which can provide relief for at least 3 years and aims to retain the natural function and anatomy of the disc. MPCs offer the possibility to support and promote the existing regenerative potential inherent in host tissues and are expected to deliver superior long term outcomes compared to purely symptomatic treatments."
From the above the Phase II trial was to provide relief and also aimed to retail natural function and anatomy of the disc.
2. Phase 2 Trial
MPC-06-ID was evaluated in a randomized, placebo and active controlled Phase 2 trial conducted in 100 patients with more than six months of CLBP due to disc degeneration.
In March 2017, 36-month results were released and showed that a single intra-discal injection of 6 million MPCs resulted in meaningful improvements in both pain and function that were durable for at least three years. Previously, 24-month results were presented at the 24th Annual Scientific Meeting of the Spine Intervention Society in July 2016, and received the 2016 Best Basic Science Abstract award at the New Orleans meeting.
3. Ongoing Phase Trial 3
A Phase 3 clinical program has completed enrollment of 404 patients.
This Phase 3 clinical trial will use a primary endpoint that comprises both pain relief and improved function, consisting of a 50% reduction in lower back pain as measured by Visual Analog Score and a 15-point improvement in Oswestry Disability Index, with no additional interventions.
4. 30 June 2021 announcement
We look forward to discussing with the FDA the most efficient path forward given the durable pain reduction for at least two years and the opioid-sparing activity from a single administration of rexlemestrocel-L that was observed in the recent Phase 3 trial” said Dr Fred Grossman, Chief Medical Officer of Mesoblast.
5. 15 December 2021 announcement
Mesoblast plans to conduct an additional US Phase 3 trial which may support submissions for potential approval in both the US and EU. The trial will include at least 20% of subjects from the EU to support global submission plans. Following review of the completed Phase 3 trial data, OTAT agreed with Mesoblast’s proposal for pain reduction at 12 months as the primary endpoint of the next trial, with functional improvement and reduction in opioid use as secondary endpoints.
It would appear that stem cells are still in its infant stage of development and I would reckon that more research needs to be done to understand fully how such cells can be used to treat and regenerate tissues. Perhaps this is one of the reasons why the FDA is reluctant to approve such treatments and requesting more trials and the other questions that they need clarification on.
I would like to think that GVHD is probably the best treatment for approval due to the product being used in Japan for a number of years now and this would be a good start for MSB, with a steady income stream being generated, which could see a positive cashflow eventuating and then they can focus on the CHF and CLBP and the other treatments in the pipeline.
I do think that MSB lost its way in trying to get a number of treatments to trials rather than trying to put all efforts on one or two.
The costs of their treatments are not cheap and for CLPB if the primary end point is pain reduction, I do hope that the the secondary endpoints of functional improvement and reduction in opioid use can justify the costs.
Many of us have had a long journey and we are due for some rewards.
(20min delay)
