Osteoarthritis, KneePhase 1/2NCT06233474
Study of Intra-articular Allocetra in Knee Osteoarthritis
A Phase 1/2 study testing Allocetra in people with Osteoarthritis, Knee, run by Enlivex Therapeutics Ltd. at 12 sites in 3 countries.
Trial summary
This is a double blind, randomized,multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra compared to placebo in patients with symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Allocetra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 26 Jan 2024to 15 Oct 2026
- Phase
- Phase 1/2
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 - 80 years.
- Chronic osteoarthritis of index knee with knee-related joint pain
- Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee.
- Knee pain assessed daily over a period of 7 days during the screening period and following wash-out of pain medications
- Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy.
- Willing to abstain from other intra-articular treatments and adhere to the protocol restrictions for concomitant medications and therapies during the study.
- Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception prior to study entry and for the duration of study participation through 4 weeks following IP administration.
Who cannot join
- Wheelchair bound.
- Immunosuppressive therapy
- Any known current or prior tumor of the index knee.
- Any known history or current intra-articular or osseous infection of the index knee.
- Any evidence of clinically significant active infection
- Any known history of inflammatory arthropathy or crystal-deposition arthropathy
Show all 16Show fewer
- Any known severe systemic cartilage and/or bone disorder, such as, but not limited to, chondrodysplasia, osteogenesis imperfecta.
- Body Mass Index (BMI) >40.
- Any major surgical cartilage treatment within 6 months
- Any ligamentous repair or malalignment correction in the index knee within 6 months
- Major injury to the index knee, such as torn ligament or severe sprain within 6 months
- Clinically relevant knee instability of the index knee
- Severe hip osteoarthritis ipsilateral to the index knee.
- Clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome.
- Known coagulopathy, or use of anticoagulation medication or antiaggregant medication;.
- certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Israel6 sites
Barzilai Medical Center
Ashkelon, 7830604
Rambam Medical Center
Haifa, 7651211
Hasharon Medical Center
Petah Tikva, 4937211
Sheba Medical Center
Ramat Gan, 5266202
Kaplan Medical Center
Rehovot, 7661041
Ichilov - Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Denmark3 sites
Sanos Clinic Nordjylland
Gandrup, 9362
Sanos Clinic Herlev
Herlev, 2730
Sanos Clinic Syddanmark
Vejle, 7100
Moldova3 sites
IMSP Institutul de Cardiologie
Chisinau, 2025
Spitalul Clininc Republican "T. Mosneaga"
Chisinau, 2025
IMSP Sptalul Clinic Municipal "Sfanta Treime"
Chisinau, 2068
About this study
Official title: A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis
This is a double blind, randomized,multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra compared to placebo in patients with symptomatic knee osteoarthritis.
Read the detailed description
Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.
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 Phase 1/2a study is comprised of an open-label safety run-in stage to characterize safety and tolerability of repeated injections of Allocetra to a target knee , followed by a double-blind randomized stage to evaluate the safety and efficacy of Allocetra repeated injections to the target knee compared to placebo, in moderate to severe knee osteoarthritis patients. Patients in both stages will be followed for up to a year following last treatment. the last treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Allocetra, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllocetraDrug
Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state
PlaceboOther
The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in phase - Allocetra increasing dose | Other | An open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the knee in different doses and select the Allocetra dose and regimen for the randomized phase. Receives: Drug: Allocetra |
| Randomization phase - Placebo. | Placebo comparator | Three intra-articular injections of placebo into the index knee. Receives: Other: Placebo |
| Randomization phase - Allocetra | Experimental | Three intra-articular injections of Allocetra at a selected dose, into the index knee. Receives: Drug: Allocetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection
Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection
Measured: 7 months following Day 0
Secondary outcomes (3)
Weekly average of knee pain.
Evaluation of change from baseline in weekly average of knee pain as measured using NRS (Numeric Rating Scale ) assessed at 3 months and 6 months from last study treatment.
Scores range from 0-10 points, with higher scores indicating greater pain intensity
Measured: 4 months and 7 months following Day 0.
Change from baseline in WOMAC total score.
Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score at 3 months, 6 months, and 12 months from last study treatment administration.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 4 months, 7 months and 13 months following Day 0.
Change in quality of life- Euro Quality of Life-5-dimension (EQ-5D) questionnaire
Change from baseline in QoL as measured by Euro Quality of Life-5-dimension (EQ-5D) questionnaire at 6 months and at 12 months from last study treatment administration.
Measured: 4 months, 7 months and 13 months following Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start26 Jan 2024
- Primary completion15 Mar 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Run-in phase followed by randomization phase
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlivex Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience Clinical Development
- Responsible party
- Sponsor
- Investigators
- Lital Weinfeld-Bergman, Study director, Senior Director of Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233474
- Sponsor's protocol ID
- ENX-CL-05-001
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Randomized, Double-Blind Placebo-controlled Study of Intra-articular Allocetra in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06233474
- Acronym / sponsor ID
- ENX-CL-05-001
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Enlivex Therapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience Clinical Development
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 31 Jan 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 is a double blind, randomized,multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra compared to placebo in patients with symptomatic knee osteoarthritis.
Detailed description
Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.
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 Phase 1/2a study is comprised of an open-label safety run-in stage to characterize safety and tolerability of repeated injections of Allocetra to a target knee , followed by a double-blind randomized stage to evaluate the safety and efficacy of Allocetra repeated injections to the target knee compared to placebo, in moderate to severe knee osteoarthritis patients. Patients in both stages will be followed for up to a year following last treatment. the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Run-in phase followed by randomization phase
| Arm | Type | Receives |
|---|---|---|
| Safety run-in phase - Allocetra increasing dose | Other | Drug: AllocetraAn open-label dose escalation phase to characterize the safety and tolerability of Allocetra injections to the knee in different doses and select the Allocetra dose and regimen for the randomized phase. |
| Randomization phase - Placebo. | Placebo comparator | Other: PlaceboThree intra-articular injections of placebo into the index knee. |
| Randomization phase - Allocetra | Experimental | Drug: AllocetraThree intra-articular injections of Allocetra at a selected dose, into the index knee. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 45 - 80 years.
- Chronic osteoarthritis of index knee with knee-related joint pain
- Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee.
- Knee pain assessed daily over a period of 7 days during the screening period and following wash-out of pain medications
- Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy.
Key exclusion criteria (16 listed)
- Wheelchair bound.
- Immunosuppressive therapy
- Any known current or prior tumor of the index knee.
- Any known history or current intra-articular or osseous infection of the index knee.
- Any evidence of clinically significant active infection
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 |
|---|---|---|
| AllocetraAllocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state | Drug | Randomization phase - Allocetra, Safety run-in phase - Allocetra increasing dose |
| PlaceboThe control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells. | Other | Randomization phase - Placebo. |
Primary outcome
Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection
Time frame: 7 months following Day 0
Number and severity of adverse events (AEs), serious adverse events (SAEs) and treatment disruptions/ discontinuations throughout the study from Day 0 and up to 6 months following the last injection
3 secondary outcomes
Weekly average of knee pain.
Time frame: 4 months and 7 months following Day 0.
Change from baseline in WOMAC total score.
Time frame: 4 months, 7 months and 13 months following Day 0.
Change in quality of life- Euro Quality of Life-5-dimension (EQ-5D) questionnaire
Time frame: 4 months, 7 months and 13 months following Day 0.
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 4 Nov 2026.
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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.
Lital Weinfeld-Bergman study director
Senior Director of Clinical Operations
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allocetra in people with Osteoarthritis, Knee, run by Enlivex Therapeutics Ltd. at 12 sites in 3 countries.
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 16 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Israel, Denmark, Moldova. 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?
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?
Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection (time frame: 7 months following Day 0). 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 4 Nov 2026.