Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis
1 other identifier
interventional
13
1 country
1
Brief Summary
Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to reduce pain, improve function, and slow down further breakdown of the knee. Recently, research on nonsurgical treatment options for knee OA has increased significantly. One potential treatment of interest is the use of stem cell injections. Stem cells are one's own cells that have the ability to divide into other types of cells, and may cause regrowth of cartilage when injected into the knee. There have been few, but promising, studies that show improvements in pain and function with stem cell injections in those with knee OA. Therefore, more research is needed to identify patients who might benefit from this injection. This pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12 months after a stem cell injection into the knee. Patients will also undergo magnetic resonance imaging at 6 months and 12 months following the injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJanuary 14, 2020
January 1, 2020
2.3 years
April 20, 2017
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr.
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
1 month after date of injection
KOOS Jr.
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
3 months after date of injection
KOOS Jr.
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
6 months after date of injection
KOOS Jr.
The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
12 months after date of injection
Secondary Outcomes (3)
Pain
1 month, 3 months, 6 months, and 12 months after date of injection
Degree of cartilage change
6 months (first 5 patients only) and 12 months after date of injection
Presence of side effects
1 month, 3 months, 6 months, and 12 months after date of injection
Study Arms (1)
Bone Marrow Aspirate (BMA) Injection
EXPERIMENTALInterventions
Bone marrow will be aspirated from the iliac crest and injected into the knee.
Bone marrow will be aspirated from the iliac crest.
Eligibility Criteria
You may qualify if:
- \>=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections
- Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone)
- Age 18-79 years
You may not qualify if:
- Presence of loose bodies on baseline magnetic resonance imaging
- Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences
- History of meniscal injury other than degenerative meniscal tears
- Previous knee surgery
- Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
- Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection
- Mechanical axis deviation greater than 7 degrees
- Intolerance to acetaminophen or hydrocodone (i.e., Vicodin)
- Use of non-steroidal anti-inflammatory drugs \<1 weeks prior to BMA
- Injection of the joint scheduled for treatment within 3 months of BMA injection
- Body mass index of 30 or more
- History of drug abuse
- Current cigarette smokers
- Current use of systemic steroids
- History of or current alcohol abuse or dependence
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
Related Publications (1)
Wells K, Klein M, Hurwitz N, Santiago K, Cheng J, Abutalib Z, Beatty N, Lutz G. Cellular and Clinical Analyses of Autologous Bone Marrow Aspirate Injectate for Knee Osteoarthritis: A Pilot Study. PM R. 2021 Apr;13(4):387-396. doi: 10.1002/pmrj.12429. Epub 2020 Jul 13.
PMID: 32500620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Lutz
Hospital for Special Surgery, New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 26, 2017
Study Start
April 28, 2017
Primary Completion
August 12, 2019
Study Completion
October 1, 2019
Last Updated
January 14, 2020
Record last verified: 2020-01