Clinical trial NCT05936060: Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes
Official title: Recovery of Joint Cartilage in Adults With Knee Osteoarthritis by Use of Mesenchymal Stromal Cells Derived From Human Umbilical Cord: Randomized Controlled Clinal Trial With Clinical and Radiologic Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS
Sponsor class: OTHER
Collaborators: name: Hospital Infantil Universitario de San Jose
First posted: 2023-07-07
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of osteoarthritis (OA) of the knee remains still controversial. Despite that fact advanced stages with symptomatic and functional improvement are obtained with total knee replacement, however, there is no treatment that neither modifies the natural history of this disease, nor avoid joint replacement surgery in young patients in whom the prosthesis has conflictive indications. Moreover, prosthetic surgery leads to lower long-term survival and in older patients, higher morbidity and mortality. Cell therapy promises to be a treatment option through the use of mesenchymal cells with the capacity control inflammatory responses and trigger the differentiation into chondrocytes. Here we propose a randomized placebo-controlled clinical trial to evaluate radiologic and clinical outcomes in patients with knee OA.


Eligibility criteria: Inclusion Criteria:

Pain most days for the last month. Presence of osteophytes. Synovial fluid with mechanical characteristics. Morning stiffness for less than 30 minutes in the affected joint. Patellar crepitus. Patients aged 40 years or older and less than 60 years. Radiological criteria for osteoarthritis of the knee Kellgren-Lawrence 2 to 4 in comparative radiographs with knee support taken in the last 12 months prior to consultation.

Pain in one or both knees according to a visual analogue scale of 5 or more, out of 10 points in the last 3 months.

Exclusion Criteria:

Consumption of non-steroidal anti-inflammatory drugs or anticoagulants in the last 14 days.

Patient with a history of joint infiltration or arthroscopic surgery of the affected knee in the last 6 months.

Participants in another treatment or research study within the past year. Pregnant or lactating patients. Patient with active tumor pathology or a history of oncological disease. Patient with metabolic disease and/or uncontrolled coagulopathy at the assessment time.

Patients who have received previous treatments such as microfractures, and osteochondral allografts.

Patients with present meniscal lesions. Patients with a history of thyroiditis or thyroid nodules with increased antithyroglobulin antibodies.

Patients with a history of osteoarticular infection in the last 5 years or active at the time of assessment.

Primary outcomes:
measure: Changes in Visual Analogue scale (VAS)
timeFrame: 30 months (day 0, day 1, month 1, month 3, month 6, year 1 and year 2
measure: Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 30 months (day 0, month 3, month 6, year 1 and year 2)
measure: Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0)
timeFrame: 30 Months (day 0, year 1 and year 2)
Secondary outcomes:
Other outcomes:
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