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Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130335
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: BMA Injection Biological: BMA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bone Marrow Aspirate (BMA) Injection 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.


Outcome Measures
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Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr. [ Time Frame: 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.

  2. KOOS Jr. [ Time Frame: 3 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.

  3. KOOS Jr. [ Time Frame: 6 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.

  4. KOOS Jr. [ Time Frame: 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 :
  1. Pain [ Time Frame: 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.

  2. Degree of cartilage change [ Time Frame: 6 months (first 5 patients only) and 12 months after date of injection ]
    Cartilage change will be assessed via magnetic resonance imaging.

  3. Presence of side effects [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130335


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Gregory Lutz Hospital for Special Surgery, New York
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03130335    
Other Study ID Numbers: 2016-0435
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases