A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis

Simple item page
dc.coverageDOI: 10.1093/stcltm/szad088
dc.creatorMatas, Jose
dc.creatorGarcía, Cynthia
dc.creatorPoblete, Daniela
dc.creatorVernal, Rolando
dc.creatorOrtloff, Alexander
dc.creatorLuque-Campos, Noymar
dc.creatorHidalgo, Yessia
dc.creatorCuenca, Jimena
dc.creatorInfante, Catalina
dc.creatorCadiz, Maria Ignacia
dc.creatorKhoury, Maroun
dc.creatorLuz-Crawford, Patricia
dc.creatorEspinoza, Francisco
dc.date2024
dc.date.accessioned2025-11-18T19:49:42Z
dc.date.available2025-11-18T19:49:42Z
dc.description<p>Osteoarthritis (OA) is the most common degenerative joint disease. Mesenchymal stromal cells (MSC) are promising cell-based therapy for OA. However, there is still a need for additional randomized, dose-dependent studies to determine the optimal dose and tissue source of MSC for improved clinical outcomes. Here, we performed a dose-dependant evaluation of umbilical cord (UC)-derived MSC (Celllistem) in a murine model and in knee OA patients. For the preclinical study, a classical dose (200.000 cells) and a lower dose (50.000 cells) of Cellistem were intra-articularly injected into the mice knee joints. The results showed a dose efficacy response effect of Cellistem associated with a decreased inflammatory and degenerative response according to the Pritzker OARSI score. Following the same approach, the dose-escalation phase I clinical trial design included 3 sequential cohorts: low-dose group (2×10<sup>6</sup> cells), medium-dose group (20×10<sup>6</sup>), and high-dose group (80×10<sup>6</sup>). All the doses were safe, and no serious adverse events were reported. Nonetheless, 100% of the patients injected with the high-dose experienced injection-related swelling in the knee joint. According to WOMAC total outcomes, patients treated with all doses reported significant improvements in pain and function compared with baseline after 3 and 6 months. However, the improvements were higher in patients treated with both medium and low dose as compared to high dose. Therefore, our data demonstrate that the intra-articular injection of different doses of Cellistem is both safe and efficient, making it an interesting therapeutic alternative to treat mild and symptomatic knee OA patients. Trial registration ClinicalTrials.gov NCT03810521.</p>eng
dc.identifierhttps://investigadores.uandes.cl/en/publications/5285fce5-877e-4344-9192-21391d779778
dc.identifier.urihttps://repositorio.uandes.cl/handle/uandes/56218
dc.languageeng
dc.rightsinfo:eu-repo/semantics/openAccess
dc.sourcevol.13 (2024) nr.3 p.193-203
dc.subjectdose escalation
dc.subjectmurine OA model
dc.subjectosteoarthritis
dc.subjectphase I clinical trial
dc.subjectumbilical-cord-derived mesenchymal stromal cells
dc.titleA Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritiseng
dc.typeArticleeng
dc.typeArtículospa
Files
Collections
PURE