Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

September 2, 2014 updated by: barbara krutchkoff, Institute of Regenerative and Cellular Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90020
        • Recruiting
        • Dr John Huh
        • Contact:
        • Principal Investigator:
          • John Huh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment with A3 SVF
These patients that have been treated. The control patients that have not been treated.
Procedure: treatment with A3 SVF
Treatment interarticular and IV with A3 SVF
Other Names:
  • A3 SVF, Cell Extracts, Adipose Derived Stem Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain and Mobility Assessment
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Regenerative and Cellular Medicine

Investigators

  • Study Chair: Barbara Krutchkoff, Institute of Regenerative and Cellular Medicine
  • Principal Investigator: John Huh, MD, ICMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

September 4, 2014

Last Update Submitted That Met QC Criteria

September 2, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3-912-OA-801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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