Osteoarthritis (OA) of the KneeNCT06718478
First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis
A study testing SakuraBead Resorbable Microspheres in people with Osteoarthritis (OA) of the Knee and Osteoarthritis Knee Pain, run by CrannMed at 1 site in Uzbekistan.
Trial summary
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Osteoarthritis Knee Pain, Joint Diseases
- What is being tested?
- SakuraBead Resorbable Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUzbekistan
- Study dates
- 5 Dec 2023to 23 Aug 2024
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able and willing to provide written informed consent, and
- Clinical diagnosis of knee OA, and
- Moderate to severe knee pain (VAS ≥ 5), and
- Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
- Age 40 years or older.
- Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).
Who cannot join
- Severe knee OA (Kellgren-Lawrence grade 4)
- Current infection of target joint, or
- Life expectancy less than 24 months, or
- Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
- Prior knee replacement surgery in the target knee, or
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- Complete meniscal or cruciate tear that requires surgery, or
- History of uncorrectable coagulopathy, or
- Prior iodinated contrast reaction resulting in anaphylaxis, or
- Pregnant and/or lactating female, or
- At the discretion of the Principal Investigator
- Subject has evidence of arterial occlusion precluding catheterization.
- Subject has occlusion of the genicular arteries.
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site
The Republican Specialized Scientific and Practical Medical Center of Therapy and Medical Rehabilitation
Tashkent
About this study
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.
Read the detailed description
To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthritis Knee Pain, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis
- Being tested
- SakuraBead Resorbable Microspheres
- Keywords
- Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SakuraBead Resorbable MicrospheresDevice
Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
| Study group | Role | What they receive |
|---|---|---|
| Genicular Artery Embolization (GAE) | Experimental | Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres Receives: Device: SakuraBead Resorbable Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.
Measured: 1 month
Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up
Measured: 1 month
Secondary outcomes (4)
Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up
Measured: 1, 3 and 6 months
Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up
Measured: 3 and 6 months
Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months
Measured: 3 and 6 months
No major device- or procedure-related complication at 3 and 6 months
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start5 Dec 2023
- Primary completion28 Mar 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrannMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718478
- Sponsor's protocol ID
- CI520
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06718478
- Acronym / sponsor ID
- CI520
- Conditions
- Osteoarthritis (OA) of the Knee, Osteoarthritis Knee Pain, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis
- Keywords
- Genicular Artery Embolization, GAE, Knee Embolization, Knee OA, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CrannMedIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 5 Dec 2024 (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.
A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.
Detailed description
To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genicular Artery Embolization (GAE) | Experimental | Device: SakuraBead Resorbable MicrospheresTemporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is able and willing to provide written informed consent, and
- Clinical diagnosis of knee OA, and
- Moderate to severe knee pain (VAS ≥ 5), and
- Pain refractory to at least 3 months* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
Key exclusion criteria (13 listed)
- Severe knee OA (Kellgren-Lawrence grade 4)
- Current infection of target joint, or
- Life expectancy less than 24 months, or
- Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
- Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
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 |
|---|---|---|
| SakuraBead Resorbable MicrospheresTemporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres | Device | Genicular Artery Embolization (GAE) |
Primary outcome
Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up.
Time frame: 1 month
Genicular Artery Embolization (GAE) without a major device- or procedure-related complication at 1 month follow-up
Time frame: 1 month
4 secondary outcomes
Reduction in global Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire at 1 month, 3 months and 6 months follow-up
Time frame: 1, 3 and 6 months
Reduction of previously initiated OsteoArthritis (OA) medical therapy at 3- and 6-months follow-up
Time frame: 3 and 6 months
Decrease of pain on Visual Analogue Scale (VAS) at 3 and 6 months
Time frame: 3 and 6 months
No major device- or procedure-related complication at 3 and 6 months
Time frame: 3 and 6 months
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SakuraBead Resorbable Microspheres in people with Osteoarthritis (OA) of the Knee and Osteoarthritis Knee Pain, run by CrannMed at 1 site in Uzbekistan.
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 7 inclusion and 13 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 5 Dec 2024. 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 Uzbekistan. 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?
Decrease of pain on Visual Analogue Scale (VAS) at 1 month follow-up. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 5 Dec 2024.