Osteoarthritis, KneeNCT03130335
Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis
A study testing BMA Injection and BMA in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- BMA Injection and BMA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- BMA Injection, BMA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMA InjectionProcedure or surgery
Bone marrow will be aspirated from the iliac crest and injected into the knee.
BMABiological
Bone marrow will be aspirated from the iliac crest.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Aspirate (BMA) Injection | Experimental | Not described Receives: Procedure: BMA Injection; Biological: BMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after date of injection
Secondary outcomes (3)
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.
Measured: 1 month, 3 months, 6 months, and 12 months after date of injection
Degree of cartilage change
Cartilage change will be assessed via magnetic resonance imaging.
Measured: 6 months (first 5 patients only) and 12 months after date of injection
Presence of side effects
The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.
Measured: 1 month, 3 months, 6 months, and 12 months after date of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start28 Apr 2017
- Primary completion12 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Lutz, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130335
- Sponsor's protocol ID
- 2016-0435
- Status last verified
- Jan 2020
- First submitted
- 20 Apr 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32500620
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
- ClinicalTrials.gov ID
- NCT03130335
- Acronym / sponsor ID
- 2016-0435
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Aspirate (BMA) Injection | Experimental | Procedure: BMA Injection, Biological: BMA |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMA InjectionBone marrow will be aspirated from the iliac crest and injected into the knee. | Procedure or surgery | Bone Marrow Aspirate (BMA) Injection |
| BMABone marrow will be aspirated from the iliac crest. | Biological | Bone Marrow Aspirate (BMA) Injection |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Pain
Time frame: 1 month, 3 months, 6 months, and 12 months after date of injection
Degree of cartilage change
Time frame: 6 months (first 5 patients only) and 12 months after date of injection
Presence of side effects
Time frame: 1 month, 3 months, 6 months, and 12 months after date of injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 32500620Wells 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Lutz principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMA Injection and BMA in people with Osteoarthritis, Knee, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr. (time frame: 1 month after date of injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.