Osteo Arthritis KneeBMACNCT04716803
Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
A study testing Bone Marrow Aspirate Concentrate and Angel Concentrated Platelet Rich Plasma (cPRP) System in people with Osteo Arthritis Knee, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Bone Marrow Aspirate Concentrate and Angel Concentrated Platelet Rich Plasma (cPRP) System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kellgren Lawrence radiographic grade IV
- Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
- Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.
- Males or females aged 45-75.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego Koman Outpatient Pavilion
La Jolla, California, 92037
Karen Cuervo, BS, 858-249-3038, kcuervo@health.ucsd.edu
Kenneth Kalunian, MD
About this study
The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.
Read the detailed description
This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Bone Marrow Aspirate Concentrate, Angel Concentrated Platelet Rich Plasma (cPRP) System
- Keywords
- moderate to severe knee osteoarthritis, total knee replacement, bone marrow, stem cell-based therapy, arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate ConcentrateBiological
Also called BMAC
Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.
Angel Concentrated Platelet Rich Plasma (cPRP) SystemDevice
Also called The Angel System
Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow aspiration concentrate using the Angel System | Experimental | Bone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study.
Bone marrow aspiration will be concentrated using the Angel System. Receives: Biological: Bone Marrow Aspirate Concentrate; Device: Angel Concentrated Platelet Rich Plasma (cPRP) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with at least one severe adverse event
The number of life-threatening severe adverse events as determined by the standard FDA guidelines for adverse events that are deemed to be related to autologous BMAC concentrated by the Angel System and delivered via intra-articular injection into the knee.
Measured: End of Study (12 months)
Secondary outcomes (2)
Structural change in knee from baseline measured by the VAS (Visual Analog Scale) in the American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS).
The VAS ranges from 0 to 100 with 0 indicating no damage and higher scores indicating more severe damage.
Measured: End of study (12 months)
Self reported health from baseline through end of study measured by the 36-Item Short Form Survey Instrument (SF-36) Health Survey and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
SF-36 scores are measured via ranges from 0 to 100.
Measured: End of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start8 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Kalunian, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716803
- Sponsor's protocol ID
- 180916
- Acronym
- BMAC
- Status last verified
- Jan 2022
- First submitted
- 3 Nov 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04716803
- Acronym / sponsor ID
- BMAC / 180916
- Conditions
- Osteo Arthritis Knee
- Keywords
- moderate to severe knee osteoarthritis, total knee replacement, bone marrow, stem cell-based therapy, arthroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2021 (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.
The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.
Detailed description
This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.
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 aspiration concentrate using the Angel System | Experimental | Biological: Bone Marrow Aspirate Concentrate, Device: Angel Concentrated Platelet Rich Plasma (cPRP) SystemBone marrow aspirate concentrate (BMAC) will be administered via injection to the knee of interest on day 14 of the study. Bone marrow aspiration will be concentrated using the Angel System. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kellgren Lawrence radiographic grade IV
- Need for a total knee arthroscopy by the patients primary care provider/or orthopedist.
- Persistent pain in target knee that is unresponsive to standard of care including acetametaphine, non-steroidal anti-inflammatory drugs, physical therapy and/or intraarticular corticosteroids and/or hyaluronic acid preparations.
- Males or females aged 45-75.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bone Marrow Aspirate ConcentrateAlso: BMACAspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System. | Biological | Bone marrow aspiration concentrate using the Angel System |
| Angel Concentrated Platelet Rich Plasma (cPRP) SystemAlso: The Angel SystemAspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System. | Device | Bone marrow aspiration concentrate using the Angel System |
Primary outcome
Patients with at least one severe adverse event
Time frame: End of Study (12 months)
The number of life-threatening severe adverse events as determined by the standard FDA guidelines for adverse events that are deemed to be related to autologous BMAC concentrated by the Angel System and delivered via intra-articular injection into the knee.
2 secondary outcomes
Structural change in knee from baseline measured by the VAS (Visual Analog Scale) in the American College of Rheumatology/Knee Osteoarthritis Assessment Scale (ACR/KOAS).
Time frame: End of study (12 months)
Self reported health from baseline through end of study measured by the 36-Item Short Form Survey Instrument (SF-36) Health Survey and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time frame: End of study (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate Concentrate and Angel Concentrated Platelet Rich Plasma (cPRP) System in people with Osteo Arthritis Knee, run by University of California, San Diego 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jan 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Kalunian, MD (858-246-2381, kkalunian@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with at least one severe adverse event (time frame: End of Study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2022.