Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Institute of Regenerative and Cellular Medicine

Status

Unknown

Conditions

Osteoarthritis

Treatments

Procedure: treatment with A3 SVF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01947348

A3-912-OA-801

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.