Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee

NCT02276833 | Completed Phase 1

• 1 other identifier: OA-001
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Autologous adipose-derived stromal vascular fraction (SVF) was used to treat 10 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study. The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 3 ml of Lactated Ringer's Solution, with a mean of 48 million nucleated SVF cells and a mean viability of 78%, injected per knee. Cell suspension was injected into the intra-articular space using ultrasound guidance. At 12 weeks post-op all 10 knees showed decreased pain and increased mobility, both statistically significant (α = .01). Nine of ten knees reported either maximum possible or very significant decrease in pain. No infections, acute pain flares, or other adverse events were reported. Patient ages ranged from 52 - 69 years with a mean of 59 years.

Conditions

Arthritis, Degenerative

Outcome Measures

Primary Outcomes (1)

• Adverse events

  any adverse event related to procedure

  12 weeks

Secondary Outcomes (1)

• Validated PROMIS pain assessments

  12 weeks

Study Arms (1)

Single patient group with qualifying OA

EXPERIMENTAL

intra-articular space injection of SVF Single patient group with pre-operative and post-operative assessments

Other: intra-articular space injection of SVF

Interventions

intra-articular space injection of SVF OTHER

intra-articular injection of autologous adipose SVF derived in the same surgical procedure

Single patient group with qualifying OA

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study Subject voluntarily gives written Informed Consent to participate in the study and signs the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
• The age range is from 20-70 years old.
• Both female and male participants are eligible.
• Females must be non-pregnant and those of child-bearing age will be pregnancy tested on-site at SMASA or RENEW on the day of, and prior to, surgery (Visit #2).
• Participants will be in good health (ASA Class I-II) with a BMI \< 35
• Failed a regimen of anti-inflammatory systemic medicines and/or physical therapy.
• Knee pain graded as greater than 4 out of 10.
• Mild to moderate arthritis as diagnosed by standard x-ray or MRI study.
• Patients will be eligible for in-office surgical procedures at SMASA and RENEW.
• Participants cannot be allergic to lidocaine, epinephrine, or valium.
• Must speak, read and understand English.

You may not qualify if:

• Outside of the age range (20-70 years old).
• BMI Index greater than 35.
• Severe to end stage osteoarthritis,Grade IV, as diagnosed by plain x-ray or MRI study.
• Hyaluronic acid gel injections to the affected knee joint within the last six months.
• Corticosteroid injections to the affected knee joint within the past 3 months.
• Current use of oral/systemic steroids.
• History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection, uncontrolled diabetes mellitus, immunodeficiency disorders (HIV), lipoatrophy disorders (scleroderma, lupus etc.), rheumatoid arthritis or any other medical condition causing chronic or clinically significant pain.
• Allergic to lidocaine, epinephrine, valium or sodium phosphate.
• Individuals with diminished decision-making capacity will not be included in this research study.
• All smokers and other tobacco users.
• Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders.

Sponsors & Collaborators

• Renew Center, San Antonio, Texas: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jaime R Garza, MD, DDS

  Renew Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jaime R. Garza, M.D.

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 28, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 28, 2014

Record last verified: 2014-10