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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: Autologous adipose tissue injection Drug: Hyaluronic Acid||Not Applicable|
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|
|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|
|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|
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.
- 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.
- 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.
- 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.
- Clinical Anchors [ Time Frame: Clinical anchors from baseline to 6 months ]Clinical anchors will be used to identify minimal important differences in treatment groups
- 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
- Short-term clinical evaluation - WOMAC [ Time Frame: Change from baseline at 6 weeks ]WOMAC questionnaire will be administered at the 6-week follow-up
- Short-term clinical evaluation - PROMIS [ Time Frame: Change from baseline at 6 weeks ]PROMIS questionnaire will be administered at the 6-week follow-up
- 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.
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
|Contact: Ryan Togashifirstname.lastname@example.org|
|United States, California|
|Keck Medicine of USC||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Ryan Togashi 323-442-6959 email@example.com|
|Principal Investigator:||C.Thomas Vangsness, MD||Keck School of Medicine of USC|