Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes (INMUNOCEM-OA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: INMUNOCEM; Drug: PLACEBO COMPARATOR

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMUNOCEM; Administration of umbilical cord-derived mesenchymal stromal cells suspension	Biological: INMUNOCEM; Mesenchymal Stromal Cell suspension intraarticularly injected; Other Names: Mesenchymal stromal cell suspension
Placebo Comparator: PLASMALYTE; Administration of plasmalyte as vehicle for MSC	Drug: PLACEBO COMPARATOR; Administration of plasmalyte as a vehicle for MSC; Other Names: PLASMALYTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: GUSTAVO SALGUERO
• Collaborators: Hospital Infantil Universitario de San Jose

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: IDCBIS-UTA-EC-01-InmunoCEM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No