NCT04863183

Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

Cell Therapy for Patients With Symptomatic Knee Osteoarthritis: Phase I / II, Controlled, Randomized and Double-blind Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide). Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis. Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained. Sample size The sample size considered are 30 participants distributed in two groups. Group 1 (control) active comparator: triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc. Group 2 (experimental): CELLISTEM-OA via intra-articular, doses of 2 x 106 cells in 5cc of saline solution. The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique, after cooling the skin with local ice.

Conditions

• Mesenchymal Stem Cells
• Knee Osteoarthritis
• Cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	CELLISTEM-OA	The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
DRUG	Triamcinolone acetonide	The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2021-04-28
• Last updated: 2021-04-28