Recruiting

A3 SVF

Sponsor:

Institute of Regenerative and Cellular Medicine

Code:

NCT01947348

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

treatment with A3 SVF

Study Details

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.

Conditions

Osteoarthritis

Study ID

NCT01947348

Start date

Sep, 2012

Status verified date

Sep, 2014

Completion date

Sep, 2015

Anticipated

Primary completion date

Sep, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: treatment with A3 SVF

These patients that have been treated. The control patients that have not been treated.

Interventions

treatment with A3 SVF

Treatment interarticular and IV with A3 SVF

Primary outcome measure

  • Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

John Huh, MD

213 384 1717

Locations

Dr John Huh

Recruiting

Los Angeles, California, United States, 90020

Contacts

John Huh, MD

213-384-1717drjhuh@gmail.com

Principal Investigator:

John Huh, MD

More Information

Sponsor

Institute of Regenerative and Cellular Medicine

Last update posted

Sep 4, 2014

Last verified

Sep, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Institute of Regenerative and Cellular Medicine on 2014-09-04.