Clinical trial NCT01885832: Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Official title: Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: autologous adipose stem cells
stromal vascular fraction
osteoarthritis
Lead sponsor: Translational Biosciences
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 adverse events. Improvements in joint function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) are anticipated.

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 ml of adipose tissue extracted from the infraumbilical area. The cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (OA). Administration will be performed by injection into the synovial space. The dosing regimen will consist of two intraarticular injection of autologous SVF into the index knee. Total injection volume will be about 30 mL in two 15 mL aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).

The purpose of this study will be to define the safety and efficacy of SVF therapy in improving joint function and the quality of life in patients with OA of the knee. We plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. The primary safety outcome will be tabulation of adverse events related to treatment. Efficacy will be quantified at 3, 6 and 12 months by the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

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Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline Kellgren-Lawrence classification at 6 months
timeFrame: 6 months
measure: Change from baseline WOMAC Assessment at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Stem Cell Instsitute
Study officials:
affiliation: Stem Cell Institute Panama
name: Jorge Paz-Rodriguez, M.D.
role: PRINCIPAL_INVESTIGATOR
References: