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Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BMA Injection
BMA
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bone Marrow Aspirate (BMA) Injection

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
Degree of cartilage change
Cartilage change will be assessed via magnetic resonance imaging.
Presence of side effects
The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.

Full Information

First Posted
April 20, 2017
Last Updated
January 13, 2020
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03130335
Brief Title
Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis
Official Title
Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone Marrow Aspirate (BMA) Injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
BMA Injection
Intervention Description
Bone marrow will be aspirated from the iliac crest and injected into the knee.
Intervention Type
Biological
Intervention Name(s)
BMA
Intervention Description
Bone marrow will be aspirated from the iliac crest.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr.
Description
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.
Time Frame
1 month after date of injection
Title
KOOS Jr.
Description
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.
Time Frame
3 months after date of injection
Title
KOOS Jr.
Description
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.
Time Frame
6 months after date of injection
Title
KOOS Jr.
Description
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.
Time Frame
12 months after date of injection
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
1 month, 3 months, 6 months, and 12 months after date of injection
Title
Degree of cartilage change
Description
Cartilage change will be assessed via magnetic resonance imaging.
Time Frame
6 months (first 5 patients only) and 12 months after date of injection
Title
Presence of side effects
Description
The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.
Time Frame
1 month, 3 months, 6 months, and 12 months after date of injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Lutz
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32500620
Citation
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.
Results Reference
derived

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Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

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