Dose-escalation of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

Universidad de los Andes, Chile

Status and phase: Unknown; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Biological: umbilical cord derived-mesenchymal stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03810521

CLT-OA1

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

CLT low-dose

Experimental group

Description:

Umbilical cord derived-mesenchymal stromal cells at a dose of 2x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Treatment:

Biological: umbilical cord derived-mesenchymal stromal cells

CLT medium-dose

Experimental group

Description:

Umbilical cord derived-mesenchymal stromal cells at a dose of 20x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Treatment:

Biological: umbilical cord derived-mesenchymal stromal cells

CLT high-dose

Experimental group

Description:

Umbilical cord derived-mesenchymal stromal cells at a dose of 80x10e6 cells / 3mL injected by an intra-articular infiltration of affected knee

Treatment:

Biological: umbilical cord derived-mesenchymal stromal cells