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Intra-articular Adipose Tissue Injections for Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03242707
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Vangsness, University of Southern California

Brief Summary:
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Autologous adipose tissue injection Drug: Hyaluronic Acid Not Applicable

Detailed Description:

In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologous cells that are often referred to as "stem cells" or "MSCs" and extra-cellular matrix (ECM). Cell therapies containing ECM are thought to have the following advantages over treatments prepared using enzymatic digestion: (1) preservation of the stromal vascular niche, which allows time-release of the regenerative factors; (2) release of bioactive molecules by exosomes, which have been demonstrated to be significantly greater in mechanically processed fat than enzymatically processed fat; and (3) maintenance of the structural and morphologic unit, which is thought to increase cell efficacy by making the cells more resilient to the harsh conditions in the recipient environment. Case reports investigating the use of autologous fat treatments show promise, but a number of questions remain unanswered. Agents injected into the joint tend to be quickly cleared from the body and ECM itself has the potential to produce inflammatory signals and induce osteoarthritis.

This study will use a Hyaluronic acid (HA) as an active control, which is the standard of care for pain associated with osteoarthritis. The use of HA as an active control for autologous cell-based therapies is well established and is the best option given the need to aspirate fat tissue from patients who will be receiving the study treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.
Masking: None (Open Label)
Masking Description: Patients will know which group they have been assigned to
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study to Evaluate the Efficacy of Intra-articular, Autologous Adipose Tissue Injections for the Treatment of Mild-to-Moderate Osteoarthritis
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous adipose tissue knee injection
Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.
Biological: Autologous adipose tissue injection

20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.

The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.

Other Name: Lipogems, Microfragmented fat

Active Comparator: Hyaluronic Acid knee injection
Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.
Drug: Hyaluronic Acid
Synvisc-One® is a high molecular weight sodium hyaluronate.




Primary Outcome Measures :
  1. The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) [ Time Frame: Change from baseline WOMAC score at 6 months ]
    WOMAC-A is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain.


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29) [ Time Frame: Change from baseline in PROMIS-29 from baseline to 6 months ]
    A collection of 4-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item.

  2. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Change from baseline in PROMIS-29 from baseline to 6 months ]
    WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

  3. Clinical Anchors [ Time Frame: Clinical anchors from baseline to 6 months ]
    Clinical anchors will be used to identify minimal important differences in treatment groups


Other Outcome Measures:
  1. Synovial fluid analysis [ Time Frame: Baseline, 6 weeks and 6 months ]
    Selected OA biomarker profiles that define different OA phenotypes predict the responses to autologous adipose tissue injections

  2. Short-term clinical evaluation - WOMAC [ Time Frame: Change from baseline at 6 weeks ]
    WOMAC questionnaire will be administered at the 6-week follow-up

  3. Short-term clinical evaluation - PROMIS [ Time Frame: Change from baseline at 6 weeks ]
    PROMIS questionnaire will be administered at the 6-week follow-up

  4. Force Plate Analysis [ Time Frame: Assessment and change from baseline to 6 weeks and 6 months ]
    Balance will be assessed using a proprietary force plate system at baseline, 6 weeks and 6 months.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 45 to 75, inclusive
  2. Normal axial alignment
  3. X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
  4. WOMAC-pain: Between 9 and 19, inclusive
  5. Willingness to participate all scheduled follow-ups
  6. Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
  7. BMI < 40

Exclusion Criteria:

  1. Pregnant or lactating
  2. Intra-articular injection within 3 months of treatment
  3. Inflammatory arthritis
  4. Any disease or active drug use that significantly compromises coagulation
  5. Significant damage and/or tears of the ACL or other supporting tissues
  6. Prior knee surgery in the last 6 months in the knee that will be injected
  7. Active tobacco use
  8. Active alcohol or substance abuse within 6 months of study entry
  9. Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
  10. Knee joint infections, skin diseases or infections in the area of the injection site
  11. Diabetes
  12. Active inhaler use
  13. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation

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 ClinicalTrials.gov identifier (NCT number): NCT03242707


Contacts
Contact: Ryan Togashi 323-442-6959 rtogashi@usc.edu

Locations
United States, California
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Ryan Togashi    323-442-6959    rtogashi@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: C.Thomas Vangsness, MD Keck School of Medicine of USC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Vangsness, Professor of Orthopaedic Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT03242707     History of Changes
Other Study ID Numbers: HS-17-00365
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents