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.

NCT05086939 | Active Not Recruiting Phase 3

• 3 other identifiers: ARTROCELL2019-002446-212024-514545-11-00
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Range of motion.

  Evaluation of clinical-functional response using Joint range-of-motion evaluation (Flexion score 0º-140º / Extension score -140º-0º / Hyperextension: positive degrees from 0).

  12 months

• Pain self-assessment.

  Evaluation of pain using Visual Analogue Scale (VAS) (Pain self-assessment score range from 0 -no pain- to 10 -maximum-).

  12 months

• Knee Osteoarthritis.

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

  12 months

• Functional response.

  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.

  12 months

• X-ray changes of osteoarthritis.

  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.

  12 months

• Radiological response using nuclear magnetic resonance imaging.

  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).

  12 months

Secondary Outcomes (5)

• Perceived general well-being.

  6, 12 and 24 months

• Feasibility assessment of a multicentre strategy production of both cell types with several Cell Production Units

  24 months

• Evaluation of presence of adverse events related with investigational medical product (IMP).

  24 months

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

  30 days

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

  30 days

Study Arms (3)

Autologous Mesenchymal Stromal Cells (MSC)

EXPERIMENTAL

Treatment with 40 millions of autologous autologous adult mesenchymal stem cells from expanded bone marrow administered intra-articularly.

Drug: Autologous MSCs

Allogenic Mesenchymal Stromal Cells (MSC)

EXPERIMENTAL

Treatment with 40 millions of adult allogeneic expanded bone marrow mesenchymal stem cells administered intra-articularly.

Drug: Allogenic MSCs

Active Control

ACTIVE COMPARATOR

Hyaluronic Acid 60mg/3ml administered intra-articularly.

Drug: Hyaluronic Acid

Interventions

Autologous MSCs DRUG

Intra-articular injection 40 million/4 ml.

Autologous Mesenchymal Stromal Cells (MSC)

Allogenic MSCs DRUG

Intra-articular injection 40 million/4 ml.

Allogenic Mesenchymal Stromal Cells (MSC)

Hyaluronic Acid DRUG

Intra-articular injection 60mg / 3 ml .

Also known as: Hyaluronic Acid 20 mg/ml

Active Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Spanish Clinical Research Network - SCReN: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (8)

Hospital Clinic

Barcelona, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fermín Sánchez-Guijo

  IBSAL - University Hospital of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Open-label, Clinical Trial comparing 3 active treatments.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: October 21, 2021
• Study Start: May 26, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)