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.
NCT ID: NCT05086939
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2021-05-26
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autologous Mesenchymal Stromal Cells (MSC)
Treatment with 40 millions of autologous autologous adult mesenchymal stem cells from expanded bone marrow administered intra-articularly.
Autologous MSCs
Intra-articular injection 40 million/4 ml.
Allogenic Mesenchymal Stromal Cells (MSC)
Treatment with 40 millions of adult allogeneic expanded bone marrow mesenchymal stem cells administered intra-articularly.
Allogenic MSCs
Intra-articular injection 40 million/4 ml.
Active Control
Hyaluronic Acid 60mg/3ml administered intra-articularly.
Hyaluronic Acid
Intra-articular injection 60mg / 3 ml .
Interventions
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Autologous MSCs
Intra-articular injection 40 million/4 ml.
Allogenic MSCs
Intra-articular injection 40 million/4 ml.
Hyaluronic Acid
Intra-articular injection 60mg / 3 ml .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic painful knee of mechanical characteristics.
3. Absence of local or systemic septic process.
4. Hemat imetric and biochemical analysis without significant alterations that contraindicate the treatment.
5. Written informed consent of the patient.
6. The patient is able to understand the nature of the study.
7. Body Mass Index 20-35 Kg/m2.
Exclusion Criteria
2. Patient \> 75 years old.
3. 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.
4. Pregnant or breastfeeding women.
5. Neoplastic disease.
6. Intra-articular infiltration of any drug in the 3 months prior to study inclusion.
7. Concurrent participation in another clinical trial or treatment with another investigational product within 30 days prior to study enrollment.
8. Allergy to gentamicin (antibiotic used in the cell culture process ).
9. Other diseases or circumstances that compromise participation in the study according to medical criteria.
18 Years
75 Years
ALL
No
Sponsors
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Instituto de Investigación Biomédica de Salamanca
OTHER
Spanish Clinical Research Network - SCReN
NETWORK
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Hospital Universitari de Bellvitge
OTHER
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
OTHER
Responsible Party
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Principal Investigators
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Fermín Sánchez-Guijo
Role: PRINCIPAL_INVESTIGATOR
IBSAL - University Hospital of Salamanca
Locations
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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 Victoria
Málaga, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Countries
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Other Identifiers
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2019-002446-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-514545-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARTROCELL
Identifier Type: -
Identifier Source: org_study_id