Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID: NCT01947348
Run by: Institute of Regenerative and Cellular Medicine
People needed: 30
Starts: 2012-09-01
Expected to finish: 2015-09-01
Last updated by the study team: 2014-09-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Dr John Huh — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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