Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis.

NCT03379168 | Completed Results FDA Device

• 1 other identifier: 17-146
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Current treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who receive mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are limited by complex regulatory issues. This interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. There have been case reports published showing favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients. The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint compared to placebo.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; mesenchymal stem cell; adipose tissue; injection; nonoperative treatment

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Pain Scale (VAS) Over Time

  Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

  Prior to procedure then post-procedure at 2 weeks

Secondary Outcomes (2)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Over Time

  Prior to procedure then post-procedure at 2 weeks

• Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time

  Prior to procedure then post-procedure at 2 weeks

Study Arms (3)

Placebo Injection

PLACEBO COMPARATOR

Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.

Drug: Saline

Corticosteroid Injection

ACTIVE COMPARATOR

Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.

Drug: Corticosteroid injection

Lipogems Injection

EXPERIMENTAL

Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.

Device: Microfragmented Adipose Tissue (Lipogems)

Interventions

Microfragmented Adipose Tissue (Lipogems) DEVICE

Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.

Lipogems Injection

Corticosteroid injection DRUG

Cortisone is a standard of care injection to reduce joint inflammation.

Corticosteroid Injection

Saline DRUG

Sterile saline injection will act as a placebo group.

Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of eighteen or older
• Diagnosis of symptomatic knee osteoarthritis
• Radiographic evidence of knee osteoarthritis. Note: For the purposes of this study, radiographic evidence of knee osteoarthritis is defined as any one or more of the following: osteophytes, joint space narrowing, loss of articular cartilage thickness, subchondral sclerosis or cysts.

You may not qualify if:

• History of treatment with any intra-articular knee injection
• Current ligament instability as demonstrated by a positive Lachman Test, Anterior or Posterior Drawer Test, or positive Valgus or Varus Stress Test.
• Known allergy to lidocaine
• Under 18 years of age
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Dustin L. Richter, MD: lead

Study Sites (1)

UNM Hospital

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dustin Richter, MD; Vice Chair of Research
• Organization: University of New Mexico Health Sciences Center

DLRichter@salud.unm.edu

505-272-4107

Study Officials

• Dustin Richter, MD

  UNM Health Sciences Center, Dept of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is not feasible to blind patients who are randomized to receive Lipogems, as adipose tissue must be obtained from the participant. However, patients randomized to receive intra-articular corticosteroids or placebo injections will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department Orthopaedic Surgery

Model Details: This study will be conducted as a randomized, placebo-controlled clinical trial. Patients will be randomized to receive either Lipogems, intra-articular corticosteroids, or a placebo injection of saline. Lipogems is cleared for use by the FDA in orthopaedics and arthroscopy and is offered as a treatment option for knee osteoarthritis. This study will be evaluating the effectiveness (not safety) of Lipogems when compared to corticosteroids and placebo. Thus, no information will be submitted to the FDA.

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 20, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 13, 2025
• Results First Posted: December 21, 2023

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)