Osteoarthritis ThumbPhase 1/2NCT06459063
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
A Phase 1/2 study testing Allocetra - Safety run-in phase and Allocetra - Randomization phase in people with Osteoarthritis Thumb, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- Allocetra - Safety run-in phase and Allocetra - Randomization phase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jun 2024to Jan 2027
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for this clinical study must fulfill all of the following:
- Age 40 years or older.
- Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.
- Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
- X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
- Blood tests from up to three months before treatment within protocol-defined limits.
Who cannot join
- Subjects not eligible for this study include those that have any of the following:
- Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand.
- History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
- Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
- Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
- Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
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- Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.
- Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
- For women of childbearing potential, a positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).
Read the detailed description
Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint.
Patients will be followed for up to a year following treatment.
- Conditions
- Osteoarthritis Thumb
- Being tested
- Allocetra - Safety run-in phase, Placebo, Allocetra - Randomization phase
- Keywords
- Allocetra, Cell therapy, Carpo-metacarpal, Osteoarthritis, Thumb, Macrophage
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocetra - Safety run-in phaseDrug
Intra-articular injection of Allocetra performed once on Day 1 of the study at different doses.
PlaceboOther
Intra-articular injection of placebo solution containing all excipients except for the Allocetra cells.
Allocetra - Randomization phaseDrug
Intra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in phase - Allocetra increasing dose | Other | A dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase. Receives: Drug: Allocetra - Safety run-in phase |
| Randomization phase - Allocetra | Active comparator | Injection of Allocetra to the 1st CMC joint in the target thumb. Receives: Drug: Allocetra - Randomization phase |
| Randomization phase - Placebo | Placebo comparator | Injection of placebo to the 1st CMC joint in the target thumb. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection-related reactions
Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Measured: Day 0 (Treatment visit).
Treatment emergent adverse events
Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.
Measured: Day 0 to 6 months.
Secondary outcomes (3)
Thumb base pain - NRS
Thumb base pain numerical rating scale (NRS; 0-10).
Measured: Screening day to 12 months.
Hand function - FIHOA
Hand function, assessed by Functional Index for Hand Osteoarthritis (FIHOA; 0-30).
Measured: Day 0 to 12 months.
Key pinch and grip strength
Key pinch and grip strength - measured with dynamometer.
Measured: Day 0 to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 Jun 2024
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
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 ThumbStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Oron, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459063
- Sponsor's protocol ID
- 0006-24-KMC
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg Br. 1994 Jun;19(3):340-1. doi: 10.1016/0266-7681(94)90085-x.
PubMed 8077824
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
- ClinicalTrials.gov ID
- NCT06459063
- Acronym / sponsor ID
- 0006-24-KMC
- Conditions
- Osteoarthritis Thumb
- Keywords
- Allocetra, Cell therapy, Carpo-metacarpal, Osteoarthritis, Thumb, Macrophage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jun 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.
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).
Detailed description
Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint.
Patients will be followed for up to a year following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety run-in phase - Allocetra increasing dose | Other | Drug: Allocetra - Safety run-in phaseA dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase. |
| Randomization phase - Allocetra | Active comparator | Drug: Allocetra - Randomization phaseInjection of Allocetra to the 1st CMC joint in the target thumb. |
| Randomization phase - Placebo | Placebo comparator | Other: PlaceboInjection of placebo to the 1st CMC joint in the target thumb. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40 years or older.
- Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.
- Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
- X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
- Blood tests from up to three months before treatment within protocol-defined limits.
Key exclusion criteria (9 listed)
- Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand.
- History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
- Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
- Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
- Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
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 |
|---|---|---|
| Allocetra - Safety run-in phaseIntra-articular injection of Allocetra performed once on Day 1 of the study at different doses. | Drug | Safety run-in phase - Allocetra increasing dose |
| PlaceboIntra-articular injection of placebo solution containing all excipients except for the Allocetra cells. | Other | Randomization phase - Placebo |
| Allocetra - Randomization phaseIntra-articular injection of selected dose of Allocetra based on the safety run-in, performed on Day 1 of the study. | Drug | Randomization phase - Allocetra |
Primary outcome
Injection-related reactions
Time frame: Day 0 (Treatment visit).
Injection-related reactions occurring during study treatment injection, including injection interruption/discontinuation.
Treatment emergent adverse events
Time frame: Day 0 to 6 months.
Treatment emergent adverse events following study treatment injection. Safety assessments beyond 4 weeks following injection will focus on events that are at least possibly related to study treatment.
3 secondary outcomes
Thumb base pain - NRS
Time frame: Screening day to 12 months.
Hand function - FIHOA
Time frame: Day 0 to 12 months.
Key pinch and grip strength
Time frame: Day 0 to 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 13 Apr 2026.
- Background: PubMed 8077824Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg Br. 1994 Jun;19(3):340-1. doi: 10.1016/0266-7681(94)90085-x.
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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 Phase 1/2 study testing Allocetra - Safety run-in phase and Allocetra - Randomization phase in people with Osteoarthritis Thumb, run by Kaplan Medical Center at 1 site in Israel.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
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?
Injection-related reactions (time frame: Day 0 (Treatment visit).). 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?
On the ClinicalTrials.gov record for NCT06459063, 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 13 Apr 2026.