Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes

NCT ID: NCT05936060

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-07-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMUNOCEM

Administration of umbilical cord-derived mesenchymal stromal cells suspension

Group Type: EXPERIMENTAL

INMUNOCEM

Intervention Type: BIOLOGICAL

Mesenchymal Stromal Cell suspension intraarticularly injected

PLASMALYTE

Administration of plasmalyte as vehicle for MSC

Group Type: PLACEBO_COMPARATOR

PLACEBO COMPARATOR

Intervention Type: DRUG

Administration of plasmalyte as a vehicle for MSC

Interventions

INMUNOCEM

Mesenchymal Stromal Cell suspension intraarticularly injected

Intervention Type: BIOLOGICAL

PLACEBO COMPARATOR

Administration of plasmalyte as a vehicle for MSC

Intervention Type: DRUG

Other Intervention Names

Mesenchymal stromal cell suspension; PLASMALYTE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Infantil Universitario de San Jose

OTHER

Sponsor Role: collaborator

GUSTAVO SALGUERO

OTHER

Sponsor Role: lead

Responsible Party

GUSTAVO SALGUERO

Research Leader Advanced Therapies Unit

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

IDCBIS-UTA-EC-01-InmunoCEM

Identifier Type: -

Identifier Source: org_study_id