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Multicenter Clinical Trial Comparing Treatment With Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control With Hyaluronic Acid in Patients With Knee Osteoarthritis (ARTROCELL) (ARTROCELL)

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ClinicalTrials.gov Identifier: NCT05086939
Recruitment Status : Active, not recruiting
First Posted : October 21, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborators:
Spanish Clinical Research Network - SCReN
Hospital Universitari de Bellvitge
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Investigación Biomédica de Salamanca
Information provided by (Responsible Party):
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Brief Summary:
Phase III, multicenter, randomized, open-label, multicenter clinical trial comparing treatment with allogeneic mesenchymal cells versus autologous mesenchymal cells and versus active control with hyaluronic acid in patients with knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Autologous MSCs Drug: Allogenic MSCs Drug: Hyaluronic Acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Open-label, Clinical Trial comparing 3 active treatments.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III, Multicenter, Randomized, Open-label, Multicenter Clinical Trial Comparing Treatment With Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control With Hyaluronic Acid in Patients With Knee Osteoarthritis
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous Mesenchymal Stromal Cells (MSC)
Treatment with 40 millions of autologous autologous adult mesenchymal stem cells from expanded bone marrow administered intra-articularly.
Drug: Autologous MSCs
Intra-articular injection 40 million/4 ml.

Experimental: Allogenic Mesenchymal Stromal Cells (MSC)
Treatment with 40 millions of adult allogeneic expanded bone marrow mesenchymal stem cells administered intra-articularly.
Drug: Allogenic MSCs
Intra-articular injection 40 million/4 ml.

Active Comparator: Active Control
Hyaluronic Acid 60mg/3ml administered intra-articularly.
Drug: Hyaluronic Acid
Intra-articular injection 60mg / 3 ml .
Other Name: Hyaluronic Acid 20 mg/ml




Primary Outcome Measures :
  1. Range of motion. [ Time Frame: 12 months ]
    Evaluation of clinical-functional response using Joint range-of-motion evaluation (Flexion score 0º-140º / Extension score -140º-0º /Hiperextension: positive degrees from 0).

  2. Pain self-assessment. [ Time Frame: 12 months ]
    Evaluation of pain using Visual Analogue Scale (VAS) (Pain self-assessment score range from 0 -no pain- to 10 -maximum-).

  3. Knee Osteoarthritis. [ Time Frame: 12 months ]
    Evaluation of Knee Osteoarthritis using Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) [measures five items for pain (score range from 0 -no pain- to 20 -maximum-), two for stiffness (score range from 0-no stiffness- to 8 -maximum-), and 17 for functional limitation (score range from 0 -no limitation- to 68 -maximum-)]

  4. Functional response. [ Time Frame: 12 months ]
    Evaluation of functional response using Lequesne Algofunctional Index (score range from 0 to 24). It includes measures of pain (5 questions), walking distance (1 question) and activities of daily living (4 questions) with separate versions for the hip and knee. The scores for each question are summed to obtain a combined score of disease severity. Scores 1 to 4 are classified as mild osteoarthrosis; 5 to 7, moderate; 8 to 10, severe; 11 to 13, very severe; and 14 and above, extremely severe.

  5. X-ray changes of osteoarthritis. [ Time Frame: 12 months ]

    Radiological response using Kellgren and Lawrence classification system (grade from 0 to 4):

    • grade 0 (none): definite absence of x-ray changes of osteoarthritis.
    • grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping.
    • grade 2 (minimal): definite osteophytes and possible joint space narrowing.
    • grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends.
    • grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.

  6. Radiological response using nuclear magnetic resonance imaging. [ Time Frame: 12 months ]
    Evaluation of radiological response using T2 mapping nuclear magnetic resonance imaging (screening visit global mean of T2 values versus 12 months visit global mean of T2 values).


Secondary Outcome Measures :
  1. Perceived general well-being. [ Time Frame: 6, 12 and 24 months ]
    Evaluation of quality of life using Short Form-12 Health Survey questionnaire (SF12) [score range from 0 (the worst health status for that dimension) to 100 (the best health status)]

  2. Feasibility assessment of a multicentre strategy production of both cell types with several Cell Production Units [ Time Frame: 24 months ]
    Rate of products not conforming to the validation criteria in each arm of experimental treatment.

  3. Evaluation of presence of adverse events related with investigational medical product (IMP). [ Time Frame: 24 months ]
    Rate of adverse events and other pharmacovigilance parameters in the three treatment arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Knee osteoarthritis Kellgren-Lawrence grade 2, 3 or 4 .
  2. Chronic painful knee of mechanical characteristics.
  3. Absence of local or systemic septic process.
  4. Hemacytometric and biochemical analysis without significant alterations that contraindicate treatment.
  5. Written informed consent of the patient.
  6. The patient is able to understand the nature of the study.
  7. NEGATIVE serologies: Syphilis, HTLVI-II, HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) and HCV PCR (must be repeated if more than 30 days elapse between its completion and the extraction of bone marrow in patients to whom autologous cells correspond).
  8. Body Mass Index 20-35 Kg/m2.

Exclusion Criteria:

  1. Patient < 18 years old, or legally dependent.
  2. Patient > 75 years old.
  3. Congenital or evolutive diseases that result in malformation and/or significant deformities of the knee (varus<10º; valgus<20º) that cause difficulties in the application and evaluation of the results.
  4. Pregnant or breastfeeding women.
  5. Neoplastic disease.
  6. Intra-articular infiltration of any drug in the 3 months prior to inclusion in the study.
  7. Concurrent participation in another clinical trial or treatment with another investigational product in the 30 days prior to inclusion in the study.
  8. Allergy to gentamicin (antibiotic used in the cell culture process).
  9. Other diseases or circumstances that may compromise the participation in the study according to medical criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086939


Locations
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Spain
Centro Médico Teknon
Barcelona, Spain
Hospital Clinic
Barcelona, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Fundación Jiménez Díaz
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Sponsors and Collaborators
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Spanish Clinical Research Network - SCReN
Hospital Universitari de Bellvitge
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Instituto de Investigación Biomédica de Salamanca
Investigators
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Principal Investigator: Fermín Sánchez-Guijo IBSAL - University Hospital of Salamanca
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Responsible Party: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
ClinicalTrials.gov Identifier: NCT05086939    
Other Study ID Numbers: ARTROCELL
2019-002446-21 ( EudraCT Number )
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents