Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

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.

Conditions

• Mesenchymal Stem Cells
• Knee Osteoarthritis
• Cell Therapy

Interventions

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.

Sponsors & Collaborators

• Cells for Cells

  collaborator INDUSTRY

• Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

  lead OTHER

Principal Investigators

• Martha L Arango, PhD · Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2021-12-31

Completion

2022-06-30