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NCT Number: NCT05086939

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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
  • Chronic painful knee of mechanical characteristics.
  • Absence of local or systemic septic process.
  • Hemat imetric and biochemical analysis without significant alterations that contraindicate the treatment.
  • Written informed consent of the patient.
  • The patient is able to understand the nature of the study.
  • Body Mass Index 20-35 Kg/m2.

Exclusion criteria

  • Patient < 18 years old, or legally dependent.
  • Patient > 75 years old.
  • Congenital or developmental diseases that translate malformation and / or significant deformations of the knee (varus>10º; valgus>20º) and condition difficulties of application and evaluation of the results.
  • Pregnant or breastfeeding women.
  • Neoplastic disease.
  • Intra-articular infiltration of any drug in the 3 months prior to study inclusion.
  • Concurrent participation in another clinical trial or treatment with another investigational product within 30 days prior to study enrollment.
  • Allergy to gentamicin (antibiotic used in the cell culture process ).
  • Other diseases or circumstances that compromise participation in the study according to medical criteria.

Treatment and study plan

Autologous MSCs

Drug

Intra-articular injection 40 million/4 ml.

Allogenic MSCs

Drug

Intra-articular injection 40 million/4 ml.

Hyaluronic acid

Drug

Intra-articular injection 60mg / 3 ml .

Other names: Hyaluronic Acid 20 mg/ml

Primary outcomes

  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 / Hyperextension: 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 outcomes

  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.

  4. Evaluation of products obtained by genomic study and potency studies of the final products of all cell types (exploratory objective)

    Time frame: 30 days

    Studies of the cell product. In this exploratory objective, genomic studies will be carried out using RNA-seq and open array on the advanced therapy drugs manufactured in the study (both autologous and allogeneic), and a correlation will be made with clinical and biological parameters and with the response.

  5. Evaluate induced changes in circulating cells of the immune system after cell treatment (exploratory objetive)

    Time frame: 30 days

    Evaluation of cell populations (NK cells, B cells, regulatory T cells, myeloid suppressor cells, T cell populations) by flow cytometry, prior to administration of cell therapy, at 7 days and 30 days.

    Evaluation of activation and inhibition markers in T lymphocytes (CD69, HLADR, CD137, PD1, LAG3 and TIM3) prior to administration of cell therapy, at 7 days and 30 days Population of inflammatory cytokines circulating in peripheral blood (Plex deB iorad -reference M50DKFADY), prior to administration of treatment, at 7 days and 30 days

Sponsors and collaborators

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Other

Collaborators

  • Hospital Universitari de Bellvitge
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer
  • Instituto de Investigación Biomédica de Salamanca
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing Treatment with Allogeneic Mesenchymal Cells Versus Autologous Mesenchymal Cells and Versus Active Control with Hyaluronic Acid in Patients with Knee Osteoarthritis

Acronym: ARTROCELL

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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