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

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
INMUNOCEM
PLACEBO COMPARATOR
Sponsored by
GUSTAVO SALGUERO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    IMUNOCEM

    PLASMALYTE

    Arm Description

    Administration of umbilical cord-derived mesenchymal stromal cells suspension

    Administration of plasmalyte as vehicle for MSC

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    June 29, 2023
    Sponsor
    GUSTAVO SALGUERO
    Collaborators
    Hospital Infantil Universitario de San Jose
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05936060
    Brief Title
    Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes
    Acronym
    INMUNOCEM-OA
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2026 (Anticipated)
    Study Completion Date
    July 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    GUSTAVO SALGUERO
    Collaborators
    Hospital Infantil Universitario de San Jose

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IMUNOCEM
    Arm Type
    Experimental
    Arm Description
    Administration of umbilical cord-derived mesenchymal stromal cells suspension
    Arm Title
    PLASMALYTE
    Arm Type
    Placebo Comparator
    Arm Description
    Administration of plasmalyte as vehicle for MSC
    Intervention Type
    Biological
    Intervention Name(s)
    INMUNOCEM
    Other Intervention Name(s)
    Mesenchymal stromal cell suspension
    Intervention Description
    Mesenchymal Stromal Cell suspension intraarticularly injected
    Intervention Type
    Drug
    Intervention Name(s)
    PLACEBO COMPARATOR
    Other Intervention Name(s)
    PLASMALYTE
    Intervention Description
    Administration of plasmalyte as a vehicle for MSC
    Primary Outcome Measure Information:
    Title
    Changes in Visual Analogue scale (VAS)
    Description
    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
    Time Frame
    30 months (day 0, day 1, month 1, month 3, month 6, year 1 and year 2
    Title
    Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
    Description
    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
    Time Frame
    30 months (day 0, month 3, month 6, year 1 and year 2)
    Title
    Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0)
    Description
    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
    Time Frame
    30 Months (day 0, year 1 and year 2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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