Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: BMA Injection; Biological: BMA

• Registration Number: NCT03130335
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Study Start: 2017-04-28
• Primary Completion: 2019-08-12
• Study Completion: 2019-10-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• >=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

Exclusion Criteria

• 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
• History of anemia, bleeding disorders, or inflammatory joint disease
• Active infection
• Active malignancy per medical or surgical history, diagnosed by primary case physician or treating specialist, undergoing treatment, has undergone treatment, or has declined treatment
• Inability to refrain from statin regimen from 1 month pre-injection to 1 month post-injection
• Pregnancy or breastfeeding at time of treatment
• Participating or planning to participate in a worker's compensation program at the time of treatment or follow-up period
• Pending or planned legal action pertaining to knee pain
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone Marrow Aspirate (BMA) Injection	BMA	-
Bone Marrow Aspirate (BMA) Injection	BMA Injection	-

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr.	1 month after date of injection	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.
KOOS Jr.	12 months after date of injection	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.

Secondary Outcome Measures

Name	Time	Method
Pain	1 month, 3 months, 6 months, and 12 months after date of injection	Pain will be assessed using the numerical rating scale (NRS), which is on a scale of 0-10. 10 represents worst pain, and 0 represents no pain.
Presence of side effects	1 month, 3 months, 6 months, and 12 months after date of injection	The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.
Degree of cartilage change	6 months (first 5 patients only) and 12 months after date of injection	Cartilage change will be assessed via magnetic resonance imaging.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States