Status:
WITHDRAWN
Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Lead Sponsor:
Translational Biosciences
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Autologous stromal vascular fraction (SVF) injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity will be safe and feasible as assessed by lack of treatment associated adve...
Detailed Description
The proposed study is a single center, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) isolated from 500...
Eligibility Criteria
Inclusion
- Age \>18 years and ability to understand the planned treatment.
- Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
- Ability and willingness to undergo liposuction
Exclusion
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or postinfectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
- Intraarticular corticosteroid injection within the previous 3 months.
- A major neurologic deficit.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
- \-
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01885832
Start Date
June 1 2013
End Date
December 1 2016
Last Update
August 10 2017
Active Locations (1)
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1
Stem Cell Instsitute
Panama City, Panama