Melbourne, Australia-based Mesoblast announced the 24-month results from its chronic low back pain product trial. The 100-patient randomized Phase 2 trial tested the company's allogenic mesenchymal precursor cells.
The study divided patients into a six million MPC dose group; 18 million MPC group; hyaluronic acid group; and saline group.
Lead investigator Michael DePalma, MD, president and medical director of Richmond-based Virginia iSpine Physicians, presented the results at the 24th Annual Scientific Meeting of the Spine Intervention Society in New Orleans.
Here are eight insights:
1. The trial revealed patients with chronic low back pain from degenerative disc disease experienced favorable long-term results when injected with the MPCs.
2. The patients experienced significant improvement in pain and function over the 24-month period, compared to control therapies.
3. The six million MPC dose proved most impactful on patients meeting the overall treatment success endpoint.
4. Compared to those patients receiving saline treatment, more patients receiving the six million MPCs achieved pain responder criteria at 12 months and 24 months.
5. More patients receiving the six million MPCs achieved functional responder criteria compared to the saline patients.
6. Half of the patients receiving six million MPCs achieved the overall treatment success endpoint compared to 18.8 percent of patients receiving saline.
7. Amount of patients achieving overall treatment success, based on group:
- Six million MPC dose group — 38.5 percent
- 18 million MPC dose group — 34.6 percent
- Hyaluronic acid group — 17.7 percent
- Saline group — 12.5 percent
8. The Phase 3 trial is ongoing, and involves 360 patients at 30 sites in the Untied States and Australia.
"If findings from the ongoing Phase 3 trial are comparable, Mesoblast's MPCs could become a valuable treatment for a significant number of people suffering with chronic low back pain who currently have no other viable option," said Dr. DePalma.