Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Procedure: treatment with A3 SVF

• Registration Number: NCT01947348
• Lead Sponsor: Institute of Regenerative and Cellular Medicine

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-04
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment with A3 SVF	treatment with A3 SVF	These patients that have been treated. The control patients that have not been treated.

Primary Outcome Measures

Name	Time	Method
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel	one year

Secondary Outcome Measures

Name	Time	Method
Pain and Mobility Assessment	one year

Trial Locations

Locations (1)

Dr John Huh; 🇺🇸 Los Angeles, California, United States