Status:
UNKNOWN
Cell Therapy With Cellistem-OA for Symptomatic Knee Osteoarthritis
Lead Sponsor:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborating Sponsors:
Cells for Cells
Conditions:
Mesenchymal Stem Cells
Knee Osteoarthritis
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Symptomatic knee osteoarthritis is a serious public health problem in the world, it carries a high personal, social and economic impact. Currently, there are no drugs that modify the natural course of...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04863183
Start Date
June 1 2021
End Date
June 30 2022
Last Update
April 28 2021
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