Status:
COMPLETED
Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)
Lead Sponsor:
Emory University
Collaborating Sponsors:
The Marcus Foundation
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-70 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
Primary osteoarthritis is a debilitating disease characterized by extensive damage to the joints and excruciating pain leading to loss of activity and depression. Despite advances in diagnosis and rel...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT03818737
Start Date
March 28 2019
End Date
May 31 2022
Last Update
July 27 2023
Active Locations (5)
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1
Andrews Institute
Gulf Breeze, Florida, United States, 32561
2
The Emory Clinic
Atlanta, Georgia, United States, 30322
3
Duke University
Durham, North Carolina, United States, 27710
4
Sanford Health
Fargo, North Dakota, United States, 58103