Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Safety and Feasibility Study of Autologous Stromal Vascular Fraction (SVF) Cells for Treatment of Osteoarthritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01885832
• Other study ID #: TBS-SVF-OA-002-2013
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: June 18, 2013
• Last updated: August 8, 2017
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Translational Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Autologous adipose tissue stromal vascular fraction

Locations

Country	Name	City	State
Panama	Stem Cell Instsitute	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Translational Biosciences

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		6 months
Secondary	Change from baseline Kellgren-Lawrence classification at 6 months		6 months
Secondary	Change from baseline WOMAC Assessment at 6 months		6 months