Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01947348

Enrollment

Registered

2013-09-20

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2014-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Brief summary

To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.

Detailed description

This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis. Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.

Interventions

PROCEDUREtreatment with A3 SVF

Treatment interarticular and IV with A3 SVF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury. * Patients range from 15-90 years of age. * Female patients not pregnant or lactating. * Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy. * Patients must be able to comply with treatment plan, laboratory tests and periodic interviews. * Patients with adequate renal function, creatinine ≤ 1.5 mg/dl. * Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT \<1.5×control.

Exclusion criteria

* Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision. * Signs and symptoms of clinically significant cardiac disease. * Diagnosis of a transient ischemic attack in the 6 months prior to screening, * Known allergy to anesthetic or any other components of study. * Patients infected with hepatitis B, C or HIV. * Patients with Body Mass Index (BMI) \> 39kg/m2 . * Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.

Design outcomes

Primary

Measure	Time frame
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel	one year

Secondary

Measure	Time frame
Pain and Mobility Assessment	one year

Countries

United States

Contacts

Primary ContactJohn Huh, MD

213 384 1717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026