Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130335
• Other study ID #: 2016-0435
• Status: Completed
• Phase: N/A
• Start date: April 28, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 1, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• BMA Injection
Bone marrow will be aspirated from the iliac crest and injected into the knee.

Biological:
• BMA
Bone marrow will be aspirated from the iliac crest.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Pain	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.	1 month, 3 months, 6 months, and 12 months after date of injection
Secondary	Degree of cartilage change	Cartilage change will be assessed via magnetic resonance imaging.	6 months (first 5 patients only) and 12 months after date of injection
Secondary	Presence of side effects	The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.	1 month, 3 months, 6 months, and 12 months after date of injection