Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cell Therapy
- Knee Osteoarthritis
- Mesenchymal Stem Cells
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide).Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The Center for Advanced Therapies will send a pre-filled syringe with the 5 cc of solution without any difference in its external appearance, regardless of the content, according to the previously randomization.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 75 years
- Gender
- Both males and females
Description
Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide). Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoa...
Type of study Controlled, randomized, double-blind clinical trial comparing CELLISTEM-OA and active comparator (triamcinolone acetonide). Study population Patients from the Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle who consult the trauma and rheumatology service by knee osteoarthritis. Patients who show interest in participating will be cited to an interview with the researchers where both the objectives and the research procedures will be explained. Sample size The sample size considered are 30 participants distributed in two groups. Group 1 (control) active comparator: triamcinolone acetonide (10mg / mL) via intra-articular, 5 cc. Group 2 (experimental): CELLISTEM-OA via intra-articular, doses of 2 x 106 cells in 5cc of saline solution. The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments using sterile technique, after cooling the skin with local ice.
Tracking Information
- NCT #
- NCT04863183
- Collaborators
- Cells for Cells
- Investigators
- Principal Investigator: Martha L Arango, PhD Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
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