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New Trial of Umbilical Cord Mesenchymal Stem Cells for Osteoarthritis Suggests Safety and Efficacy

Review of “Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial” from STEM CELLS Translational Medicine by Stuart P. Atkinson 

Successful animal trials of mesenchymal stem cell (MSC) therapy as a means to inhibit progression to osteoarthritis have encouraged the assessment of MSCs derived from various sources in human patients, including a phase I trial of allogeneic bone marrow MSCs that reported improvements in joint pain and function [1]. Multiple studies, including those from the laboratory of Francisco Espinoza (Universidad de los Andes, Santiago, Chile), have discovered that umbilical cord MSCs exhibit enhanced clonogenic, proliferative, and migratory potential, and the elevated secretion of relevant chondrogenic factors when compared to bone marrow MSCs [2, 3] (see the SCTM article here!). Overall, these studies highlight umbilical cord MSCs as an exciting source for allogeneic MSC‐based therapy for osteoarthritis [4] (see the SCTM article here and more information on the author, named the STEM CELLS Translational Medicine Young Investigator of 2018 here!).

Now, Matas et al. report the results of a phase I/II controlled, randomized, triple‐blind trial, comparing single or double intra‐articular injection of umbilical cord MSCs for the treatment of human knee osteoarthritis in a new STEM CELLS Translational Medicine study that suggests safety and efficacy [5].

Here are the details on this new trial that suggest the safety and efficacy of repeated umbilical cord MSC treatments at 12 months:

  • The study employed umbilical cord MSCs cultured and expanded in a certified Good Manufacturing Practice‐type laboratory
  • Male and female patients between 40-65 (mean 56) years of age with symptomatic knee osteoarthritis formed three treatment groups and were assessed throughout a 12-month follow‐up
    • Repeated hyaluronic acid doses at baseline and six months (employed as a comparator)
    • Single‐dose umbilical cord MSCs at baseline and placebo at six months (20 × 106 cells)
    • Repeated umbilical cord MSC doses at baseline and six months (20 × 106 cells)
  • No severe adverse events reported, suggesting safety
    • Acute synovitis appeared as the most common adverse event related to intra‐articular injection, followed by pain
  • Patients treated with repeated doses of umbilical cord MSCs experienced significant amelioration of pain and disability at 6 and 12 months, suggesting efficacy
    • Patients receiving a single umbilical cord MSC dose exhibited improvements at nine months before reaching a level of symptoms similar to hyaluronic acid-injected patients at 12 months
  • The trial failed to discover differences in chondral damage or intra‐articular calcifications from magnetic resonance imaging or the whole‐organ magnetic resonance imaging score between the three patient cohorts

While we may take great encouragement from these data, which describes a favorable safety profile and improved clinical result for the treatment of long‐term pain in knee osteoarthritis patients, the authors note certain limitations related to the small number of patients per group and the mild‐to‐moderate osteoarthritis associated with a low clinical and radiological involvement.

For more on umbilical cord MSC trials and novel stem cell therapies for osteoarthritis stay tuned to the Stem Cells Portal!

References

  1. Vega A, Martin-Ferrero MA, Del Canto F, et al., Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation 2015;99:1681-90.
  2. Bartolucci J, Verdugo FJ, Gonzalez PL, et al., Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circulation Research 2017;121:1192-1204.
  3. Gonzalez PL, Carvajal C, Cuenca J, et al., Chorion Mesenchymal Stem Cells Show Superior Differentiation, Immunosuppressive, and Angiogenic Potentials in Comparison With Haploidentical Maternal Placental Cells. STEM CELLS Translational Medicine 2015;4:1109-21.
  4. Park YB, Ha CW, Lee CH, et al., Cartilage Regeneration in Osteoarthritic Patients by a Composite of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells and Hyaluronate Hydrogel: Results from a Clinical Trial for Safety and Proof-of-Concept with 7 Years of Extended Follow-Up. STEM CELLS Translational Medicine 2017;6:613-621.
  5. Matas J, Orrego M, Amenabar D, et al., Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. STEM CELLS Translational Medicine 2019;8:215-224.