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

NCT01885832 | Withdrawn Phase 1 DMC

• 1 other identifier: TBS-SVF-OA-002-2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

autologous adipose stem cells; stromal vascular fraction; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  6 months

Secondary Outcomes (2)

• Change from baseline Kellgren-Lawrence classification at 6 months

  6 months

• Change from baseline WOMAC Assessment at 6 months

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

In the treatment arm, autologous stromal vascular fraction (SVF) will be injected into joints of 20 patients with grade 2, 3, or 4 radiographic OA severity.

Biological: Autologous adipose tissue stromal vascular fraction

Interventions

Autologous adipose tissue stromal vascular fraction BIOLOGICAL

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Biosciences: lead

Study Sites (1)

Stem Cell Instsitute

Panama City, Panama

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jorge Paz-Rodriguez, M.D.

  Stem Cell Institute Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

PA (1)