Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01947348
• Other study ID #: A3-912-OA-801
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2013
• Last updated: September 2, 2014
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2014
• Source: Institute of Regenerative and Cellular Medicine
• Contact: John Huh, MD
• Phone: 213 384 1717
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• treatment with A3 SVF
Treatment interarticular and IV with A3 SVF

Locations

Country	Name	City	State
United States	Dr John Huh	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Regenerative and Cellular Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel		one year	No
Secondary	Pain and Mobility Assessment		one year	No

External Links

•   Info regarding outcome measures
•   IRB