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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05936060
Recruitment Status : Not yet recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
Hospital Infantil Universitario de San Jose
Information provided by (Responsible Party):
GUSTAVO SALGUERO, Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: INMUNOCEM Drug: PLACEBO COMPARATOR Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: IMUNOCEM
Administration of umbilical cord-derived mesenchymal stromal cells suspension
Biological: INMUNOCEM
Mesenchymal Stromal Cell suspension intraarticularly injected
Other Name: Mesenchymal stromal cell suspension

Placebo Comparator: PLASMALYTE
Administration of plasmalyte as vehicle for MSC
Administration of plasmalyte as a vehicle for MSC

Primary Outcome Measures :
  1. Changes in Visual Analogue scale (VAS) [ Time Frame: 30 months (day 0, day 1, month 1, month 3, month 6, year 1 and year 2 ]
    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

  2. Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 30 months (day 0, month 3, month 6, year 1 and year 2) ]
    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

  3. Radiological changes in Magnetic resonance observation of cartilage repair tissue (MOCART 2.0) [ Time Frame: 30 Months (day 0, year 1 and year 2) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: GUSTAVO SALGUERO, Research Leader Advanced Therapies Unit, Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS Identifier: NCT05936060    
Other Study ID Numbers: IDCBIS-UTA-EC-01-InmunoCEM
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions