The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Intraarticular administration of 20x10\^6 MSCs
Clinica Santa Clarita
Tijuana, Estado de Baja California, Mexico
Safety evaluation of all AE/SAEs
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
Procedure tolerance (procedure pain/discomfort incidence)
The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
Time frame: 7 days after subject receives dosing
WOMAC questionnaire
The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
OAKHQOL questionnaire
The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Time frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.