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

NCT05936060 | Not Yet Recruiting Phase 2

• 1 other identifier: IDCBIS-UTA-EC-01-InmunoCEM
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Changes in Visual Analogue scale (VAS)

  The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between paints with similar conditions. Score ranges from 1 to 10, where 1 means lowest pain and 10 relates to highest pain

  30 months (day 0, day 1, month 1, month 3, month 6, year 1 and year 2

• Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)

  KOOS reflects the individual disease burden and overall joint health. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale

  30 months (day 0, month 3, month 6, year 1 and year 2)

• Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0)

  MOCART score was introduced based on 7 pertinent variables that facilitate a standardized, reproducible, semiquantitative approach for the morphological assessment of cartilage repair. Variables assesed in MOCART are: 1. Degree of cartilage defect; 2. integration into adjacent cartilage; 3. surface of the repair tissue; 4. structure of the repair tissue; 5. signal intensity of repaired tissue; 6. bony defect or bony overgrowth; 7. subchondral changes. The score ranges between 0 and 100, being 100 the maximum level of tissue compromise

  30 Months (day 0, year 1 and year 2)

Study Arms (2)

IMUNOCEM

EXPERIMENTAL

Administration of umbilical cord-derived mesenchymal stromal cells suspension

Biological: INMUNOCEM

PLASMALYTE

PLACEBO COMPARATOR

Administration of plasmalyte as vehicle for MSC

Drug: PLACEBO COMPARATOR

Interventions

INMUNOCEM BIOLOGICAL

Mesenchymal Stromal Cell suspension intraarticularly injected

Also known as: Mesenchymal stromal cell suspension

IMUNOCEM

PLACEBO COMPARATOR DRUG

Administration of plasmalyte as a vehicle for MSC

Also known as: PLASMALYTE

PLASMALYTE

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GUSTAVO SALGUERO: lead
• Hospital Infantil Universitario de San Jose: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Leader Advanced Therapies Unit

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 7, 2023

Record last verified: 2023-06