Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
NCT ID: NCT01739504
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2014-03-01
2017-04-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Intra articular infusion of AD-SVF
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
* AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment.
* Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.
Interventions
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Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Intra articular infusion of AD-SVF
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
* AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment.
* Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Active clinical infection
* Unwilling and/or not able to give written informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Ageless Regenerative Institute
INDUSTRY
Responsible Party
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Principal Investigators
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Sharon McQuillan, MD
Role: PRINCIPAL_INVESTIGATOR
Ageless Regenerative Institute
Locations
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Ageless Institute LLC
Aventura, Florida, United States
Countries
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Other Identifiers
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AD-US-OR-001
Identifier Type: -
Identifier Source: org_study_id