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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739504
Recruitment Status : Terminated (company dissolved)
First Posted : December 3, 2012
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Ageless Regenerative Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Liposuction with Local Anesthesia Biological: Intra articular infusion of AD-SVF Not Applicable

Detailed Description:
AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
Procedure: Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Other Names:
  • Lipoplasty
  • Liposculpture
  • Suction-assisted fat removal

Biological: 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.

Primary Outcome Measures :
  1. Change from Baseline in Visual Analogue Scale (VAS) [ Time Frame: 3 months, 6 months ]
    For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.

  2. Change from Baseline of Quality of life scores [ Time Frame: 3 months, and 6 months ]
  3. Change from Baseline of Reduction in analgesics [ Time Frame: Baseline, 3 months, 6 months ]
  4. Number of adverse events reported [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739504

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United States, Florida
Ageless Institute LLC
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Ageless Regenerative Institute
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Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute

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Responsible Party: Ageless Regenerative Institute Identifier: NCT01739504     History of Changes
Other Study ID Numbers: AD-US-OR-001
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ageless Regenerative Institute:
Joint pain
Articular cartilage
Mesenchymal stem cells
Adipose tissue

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Central Nervous System Depressants
Physiological Effects of Drugs