Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis
Status:
Not yet recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a
high personal, social and economic impact. Currently, there are no drugs that modify the
natural course of the disease. As analgesic therapy becomes insufficient, more invasive
measures are applied, ultimately leading to arthroplasty.
The scientific community has joined efforts to develop new therapeutic approaches that allow
the delay and regeneration of injured tissue in these patients. These include cell therapy
with mesenchymal stem cells derived from different sources. Although most of the clinical
studies carried out in different parts of the world with this therapy in patients with knee
osteoarthritis have shown therapeutic benefit, it is necessary to develop clinical trials
with high quality in our population.
The aim of this project is to evaluate the safety, tolerance and efficacy of Cellistem-OA
(biological therapy based on mesenchymal stem cells derived from Wharton's jelly of umbilical
cord) in patients with knee osteoarthritis in the Colombian population.
Investigators proposed to carry out an experimental (clinical trial), randomized, controlled
and parallel with 30 participants with knee knee osteoarthritis of the medical complex
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle. The participants will be
randomized into two groups: i) 15 patients who will receive a dose of 2 x 106 Cellistem-OA
and ii) 15 patients who will receive an active comparator (acetonide of triamcinolone 10mg /
mL), which will be administered by intra-articular injection in the superolateral aspect of
the knee. The outcomes to be evaluated will be: (i) decrease in joint pain, (ii) increase in
joint functionality, (iii) improvement in quality of life and (iv) improvement of articular
cartilage. These parameters will be evaluated at weeks 1, 4, 8, 12, 24, 25, 28, 32, 36 and 52
post-treatments. Additionally, local and systemic adverse events will be recorded to
establish whether or not there is an association between them and the intervention.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle