TerminatedNot Applicable

Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.

Stopped: company dissolved

United States10 participantsStarted 2014-03-01

Plain-language summary

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and Females between Age 18 and 80 years. * Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology * Up to date on all age and gender appropriate cancer screening per American Cancer Society. Exclusion Criteria: * Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study. * Life expectancy \< 6 months due to concomitant illnesses. * Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status * Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * Patients on chronic immunosuppressive transplant therapy * Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg * Resting heart rate \> 100 bpm; * Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * History of cancer (other than non-mela…

What they're measuring

Change from Baseline in Visual Analogue Scale (VAS)

Timeframe: 3 months, 6 months

Change from Baseline of Quality of life scores

Timeframe: 3 months, and 6 months

Change from Baseline of Reduction in analgesics

Timeframe: Baseline, 3 months, 6 months

Number of adverse events reported

Timeframe: 6 months

Trial details

NCT IDNCT01739504

SponsorAgeless Regenerative Institute

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04-01

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