Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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A phase I dose-escalation trial to assess safety and efficacy of allogeneic MSC based-treatment (cellistem-OA) in patients with symptomatic knee osteoarthritis

Official Title
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A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: umbilical cord derived-mesenchymal stromal cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between 30 and 75 years old Knee-OA Kellgren Lawrence grade I to III Pain density according to visual analogue scale superior or equal to 50 mm Patelar condromalacia grade I to III Stable joint with normal physical exploration Exclusion Criteria: Bilateral symptomatic disease Local or systemic infection Neoplasia Immunosuppression state Pregnancy Anticoagulant therapy Other types of arthritis Symptomatic disease of hip and/or spine Intra-articular infiltration with steroids in the last 3 months Intra-articular infiltration with hyaluronic acid in the last 12 months

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLT low-dose<br>Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee | Biological: umbilical cord derived-mesenchymal stromal cells<br>* Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells<br>|
| Experimental: CLT medium-dose<br>Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee | Biological: umbilical cord derived-mesenchymal stromal cells<br>* Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells<br>|
| Experimental: CLT high-dose<br>Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee | Biological: umbilical cord derived-mesenchymal stromal cells<br>* Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC score |  | 6 months | 
| Change in VAS score |  | 6 months | 
| Changes in structural joint assessment by MRI |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal stromal cells