Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis

Launched by FUNDACIÓN OFTALMOLÓGICA DE SANTANDER CLÍNICA CARLOS ARDILA LULLE · Apr 23, 2021

Keywords

ClinConnect Summary

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 compa...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients who / with:
• • Osteoarthritis of the knee.
• • Kellgren II or III to knee radiography.
• • 30 to 75 years inclusive.
• • Pain scale greater than 40 over 100 mm.
• • MRI with G I, II or III chondral knee injury with or without stable degenerative meniscal injury.
• • Stable knee.
• • Examination of the rest of the normal limb.
• • Willingness to participate in the study for 1 year.
• • Ability to understand and willingness to sign the informed consent.
• Exclusion Criteria:
• Patients who / with:
• • Symptomatic contralateral knee osteoarthritis.
• • Significant knee trauma in the preceding 3 months.
• • Wound or skin lesion in the knee studied.
• • Anatomical valgus greater than 10º.
• • Anatomical varus greater than 5º.
• • Clinically significant joint effusion.
• • Edema greater than 20% of the surface of the plateau or condyle in NMR.
• • Previously known alterations in the hip and / or spine.
• • Predominant patellofemoral pathology (radiographs with IWANO II osteoarthritis or more).
• • Any type of inflammatory arthritis.
• • History of active infections including HIV, HBV and HCV.
• • Results of laboratory tests (hemogram and CRP) outside the normal ranges.
• • Presence of fever on day -1 or day 0.
• • Use of oral corticosteroids.
• • Use of anticoagulants.
• • Immunosuppression, uncontrolled diabetes mellitus, hyperthyroidism, psychiatric illnesses
• • Active neoplasia or during the preceding 5 years.
• • Pregnancy or breastfeeding (b-Hcg positive).
• • Use of drugs or alcoholism.
• • IA injections or knee surgeries in the last 180 days.
• • BMI\> 35.
• • Any type of metallic implant susceptible to displacement with MRI.
• • Use of pacemakers.
• • History of severe allergy or anaphylactic shock.
• • Significant alterations in the evaluation of the initial laboratory tests.
• • Any factor that, in the opinion of the investigator, may affect the adequate follow-up of the patient during the study