Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is a multicenter trial conducted to compare the effectiveness of corticosteroid control to mesenchymal stem cell 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, including Emory University. A total of 480 participants will be enrolled in this study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: The Marcus Foundation
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age >40 but <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 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 ≤ 7 days 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

Exclusion Criteria:

• Clinically apparent tense effusion of the targeted knee

• Significant valgus/varus deformities (+/- 5 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.)

• Use of NSAIDS within 1 week of 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

• If deemed medically inappropriate or noncompliant by the treating investigator

• Uncontrolled diabetes

• Subject has an active workers' compensation case in progress

• Subject with insufficient amount of subcutaneous tissue to allow recovery of a minimum of 100 mL of lipoaspirate

• 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 and 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