Knee OsteoarthritisPhase 2NCT02958267
Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee
A Phase 2 study testing BMAC injection, PRP injection and Gel-One® hyaluronate injection in people with Knee Osteoarthritis, run by OhioHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BMAC injection, PRP injection and Gel-One® hyaluronate injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 40 to 70 years old
- Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
- Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
- Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
- Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
- Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy
Who cannot join
- Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
- History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
- History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
- Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
- Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
- Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
Show all 17Show fewer
- Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given
- History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses
- Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
- Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator
- Currently pregnant, nursing, or planning to become pregnant during the trial period
- Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins
- Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
- Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment
- Current cigarette smoker
- Unable to give informed consent
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
McConnell Spine, Sport, and Joint Physicians
Columbus, Ohio, 43214
About this study
Official title: Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life
The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- BMAC injection, PRP injection, Gel-One® hyaluronate injection
- Keywords
- knee osteoarthritis, regenerative medicine, orthobiologics, cellular therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC injectionBiological
60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injectionBiological
60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
Gel-One® hyaluronate injectionDevice
Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| BMAC injection and PRP injection | Experimental | Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. Receives: Biological: BMAC injection; Biological: PRP injection |
| Gel-One® hyaluronate injection | Active comparator | Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). Receives: Device: Gel-One® hyaluronate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score
Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
Measured: Change from baseline to 3, 6, and 12 months post-treatment
Secondary outcomes (2)
Numeric Pain Rating Scale
Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain"
Measured: Change from baseline to 3, 6, and 12 months post-treatment
Patient Reported Outcome Measurement Information System Global Health Scores
The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, \& Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value.
Measured: Change from baseline to 3, 6, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Ruane, OhioHealth
- Investigators
- Joseph J Ruane, DO, Principal investigator, Medical Director, McConnell Heart Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958267
- Sponsor's protocol ID
- OH1-16-00672
- Status last verified
- Sep 2019
- First submitted
- 3 Nov 2016
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ruane JJ, Ross A, Zigmont V, McClure D, Gascon G. A Single-Blinded Randomized Controlled Trial of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee with Active Control. J Stem Cells Regen Med. 2021 Jan 2;17(1):3-17. doi: 10.46582/jsrm.1701002. eCollection 2021.
PubMed 34434003
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life
- ClinicalTrials.gov ID
- NCT02958267
- Acronym / sponsor ID
- OH1-16-00672
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, regenerative medicine, orthobiologics, cellular therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC injection and PRP injection | Experimental | Biological: BMAC injection, Biological: PRP injectionInjection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint. |
| Gel-One® hyaluronate injection | Active comparator | Device: Gel-One® hyaluronate injectionGel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 40 to 70 years old
- Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
- Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
- Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
- Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
Key exclusion criteria (17 listed)
- Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
- History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
- History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
- Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
- Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
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 |
|---|---|---|
| BMAC injection60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician. | Biological | BMAC injection and PRP injection |
| PRP injection60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician. | Biological | BMAC injection and PRP injection |
| Gel-One® hyaluronate injectionPatients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance. | Device | Gel-One® hyaluronate injection |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: Change from baseline to 3, 6, and 12 months post-treatment
Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: Change from baseline to 3, 6, and 12 months post-treatment
Patient Reported Outcome Measurement Information System Global Health Scores
Time frame: Change from baseline to 3, 6, and 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34434003Ruane JJ, Ross A, Zigmont V, McClure D, Gascon G. A Single-Blinded Randomized Controlled Trial of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee with Active Control. J Stem Cells Regen Med. 2021 Jan 2;17(1):3-17. doi: 10.46582/jsrm.1701002. eCollection 2021.
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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.
Joseph J Ruane, DO principal investigator
Medical Director, McConnell Heart Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMAC injection, PRP injection and Gel-One® hyaluronate injection in people with Knee Osteoarthritis, run by OhioHealth 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 6 inclusion and 17 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 24 Sep 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: Change from baseline to 3, 6, and 12 months post-treatment). 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 NCT02958267, 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 24 Sep 2019.