Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

The study is a multicenter trial conducted to compare the effectiveness of an injection of a corticosteroid control to mesenchymal stem cell (MSC) preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third-party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). The study will be conducted in 4 sites in the United States, and a total of 480 participants will be enrolled in this study.

Key facts

Study ID

NCT03818737

Run by

Emory University

People needed

475

Starts

2019-03-28

Expected to finish

2022-05-31

Last updated by the study team

2023-07-27

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater or equal to 40 but less than or equal to 70 years old
• Males and females
• Recent knee radiograph of the targeted knee (standing anteroposterior (AP) lateral and sunrise view)
• Diagnosis of OA in the targeted knee (radiographic evidence of OA in the medial and/or lateral tibiofemoral compartment, which would include one or more osteophytes on a standard radiograph taken within 3 months)
• Continued OA pain in the targeted knee despite conservative measures (per treating provider's discretion)
• Average daily Visual Analog Scale (VAS) ≥3
• Kellgren-Lawrence system of Grade II, III, or IV
• Subjects may have concomitant patellofemoral but they must have stage II or higher generalized knee OA
• Females of childbearing potential only, must have a negative pregnancy test done at screening prior to enrollment in the study
• Women and men of child-producing potential must agree to use acceptable contraception methods for the duration of the trial such as birth control pills or condoms with spermicide

You may not qualify if…

• Clinically apparent tense effusion of the targeted knee
• Significant valgus/varus deformities (+/- 10 degrees)
• Viscosupplementation within 6 months in the targeted knee
• Other biologic injection (PRP or stem cell) within 1 year in the targeted knee
• Surgery in the targeted knee within the past 6 months (either open or scope)
• Systemic or intra-articular injection of corticosteroids in any joint within 3 months before screening
• Daily opioid use for the past three months
• History of malignancy in the previous 5 years prior to study entry, with the exception of in-situ cancers treated only by local excision with curative intent
• History of, or ongoing, autoimmune disorder that requires treatment with an immunosuppressive medication
• Active, suspected, or prior infection to the joint in the targeted knee
• Part of a vulnerable population per Office for Human Research Protections (OHRP) definition (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc.)
• Unwilling to discontinue the use of Non-Steroidal Anti-Inflammatory (NSAID)s for 7 calendar days prior to the procedure
• Unwilling to discontinue use of NSAIDS for 5 calendar days after procedure
• History of bleeding disorders or inflammatory joint disease
• Inability to hold anti-platelet therapy according to treating provider prior to procedure
• Subject is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
• Uncontrolled diabetes
• Subject has an active workers' compensation case in progress with targeted knee
• Subject with insufficient amount of subcutaneous tissue
• Hemoglobin less than 10g/dL at the time of screening
• Leukocytes <3,000/μL; neutrophils <1,500/μL; lymphocytes <800/μL; platelets <100,000/μL at the time of screening
• Diagnosis of liver disease as defined by alanine aminotransferase (ALT) >3x the upper limit of age-determined normal (ULN) or total bilirubin > 1.5x ULN
• Subjects who have had greater than 3 corticosteroid injections in the targeted knee in the 12 months prior to screening or at the physician's discretion
• Subjects with a known diagnosis of osteoporosis
• Subjects with anticipated use of systemic corticosteroids during the study period for treatment of a chronic medical condition

Where it is running

• Andrews Institute — Gulf Breeze, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Duke University — Durham, North Carolina, United States
• Sanford Health — Fargo, North Dakota, United States
• Sanford Health — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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