Here is one review article from Nov 18 that does discuss briefly an overview of companies status in line with MSB. Part cut / paste below.
Few other links to other papers & reviews from late last year to mid this year on discs etc (MSB is used in tables with other clinical trials in one). GL
Advancements in the treatment of degenerative disc disease
Allogeneic cell-based technologies
Mesoblast,[44]DiscGenics[45]and SpinalCyte[46]are the leading companies that are conducting clinical trials with allogeneic cell-based therapies in an attempt to halt degeneration and/or reverse the degenerative cascade of lumbar disc.
Mesoblast
Mesoblast uses 6 million expanded allogeneic mesenchymal precursor cells (MPCs) that are injected directly into a targeted disc in an outpatient procedure. Preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytesin vitroand by resident cells in the nucleus and annulusin vivo. MPCs have also been shown to produce anti-inflammation factors.[47],[48],[49]
In March 2017, Mesoblast released their phase II 36-month follow-up results which showed that a single intradiscal injection of 6 million MPCs resulted in meaningful improvements in both pain and function. Currently, Mesoblast is in the process of enrolling 360 patients in their phase III randomised, double-blind, placebo-controlled study.
DiscGenics
DiscGenics isolate cells directly from donor adult human disc tissue and expand these cells into therapeutic progenitor cells (discogenic cells). Since 2012, extensive preclinical evaluation has been performed on discogenic cells and injectable discogenic cell therapy (IDCT) utilising a wide variety of scientific approaches includingin vitroassays, microscopy, biochemical evaluations andin vivomodelling. The findings have been presented at both national and international scientific conferences.[50],[51],[52]
In October 2017, DiscGenic received the U.S. FDA acceptance for initiating clinical Investigational New Drug (IND) of its IDCT. DiscGenics’ IND is a phase I/II prospective, randomised, double-blinded, vehicle- and placebo-controlled, to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar IVD degeneration. The 60-subject trial is expected to begin enrolling in the U.S. in Q3 2018[Figure 6].
Figure 6: Flowchart illustrating the process of isolating and expanding discogenic cells
Fibroblasts are the least specialised cells in the connective tissue family that secrete a non-rigid extracellular matrix, including type I and/or type II collagen. Human dermal fibroblasts (HDFs) have the potential to differentiate into a chondrocyte-like cell, which are similar cell types that make up the IVD.[53]HDFs can be removed easily via a punch biopsy and expanded before being directly injected into the injured spinal disc region.[54]
Preclinical and clinical studies have shown that normal HDFs (nHDFs) embedded in human collagen-based extracellular matrix can integrate well into the host and help heal surgical wounds.[55],[56]
Preclinical studies conducted by SpinalCyte illustrate that HDF cells are a promising option for cell therapy that may restore structure and height and reduce symptoms of degenerated discs.[46]In other preclinical studies, discs showed an increased expression of structural genes, such as collagen type I and II, and the contents of structural proteins, such as proteoglycan.[57]
In March 2017, SpinalCyte announced the first injection of fibroblasts for regeneration of the spinal disc. SpinalCyte is preparing for IND phase I submission and expects to enter clinical trials in the near future. SpinalCyte aims to show that using its off-the-shelf, allogeneic ‘pre-packaged’ cell therapy product, CybroCell will lead to a reduction in pain, improved function and regeneration of damaged discs.
NuQu by ISTO
ISTO's NuQu uses expanded allogeneic juvenile cartilage chondrocytic cells. Several preclinical studies have shown the regenerative effects of allogeneic non-disc-derived chondrocytes on disc repair in animal models.[32],[58],[59]After the positive preclinical studies, ISTO initiated a phase I single-arm, prospective feasibility study for the treatment of DDD for single-level DDD using NuQu, the results of phase I study were promising[60]and a subsequent prospective, randomised, double-blinded, placebo-controlled study was initiated. ISTO completed enrolment of its phase II clinical trial; however, ISTO has terminated the programme and stopped the study after completion of phase II, most probably due to statistical equivalency between the treatment arm and placebo.[61]
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