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Primary Knee OsteoarthritisPhase 2NCT07580716

Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

A Phase 2 study testing Allocetra in people with Primary Knee Osteoarthritis, run by Enlivex Therapeutics Ltd. at 17 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA). Read more about this study

Who is it for?
Ages 64 years and older
Conditions the study is for
Primary Knee Osteoarthritis
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
182 participants
Where
17 sitesin 3 countries
Study dates
1 May 2026to Apr 2028
Phase
Phase 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 64 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the inclusion criteria listed below to be eligible for the study:
  • Age 64 years or above.
  • Diagnosis of primary femorotibial knee OA.
  • Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
  • Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
  • Index knee pain assessed during the screening period and following wash-out of pain medications.
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  • Willingness to abstain from prohibited medications/treatments during the trial.
  • Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

Who cannot join

  • Participants will be excluded from the study if they meet any of the following criteria:
  • Severe or end-stage osteoarthritis of the index knee.
  • Clinically significant structural abnormalities or instability of the index knee.
  • Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
  • Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
  • Any known history of inflammatory arthropathy or crystal-deposition disease.
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  • Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
  • Clinically significant widespread pain syndromes.
  • Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
  • Body Mass Index (BMI) >40 kg/m²
  • Use of medications that may interfere with pain assessment or study outcomes.
  • Known coagulopathy or use of anticoagulant/antiaggregant medication.
  • Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Trial locations and contacts

17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Lior Binder contact

+972-54-8054599

lior@enlivex.com

Lital Weinfeld Bergman contact

lital@enlivex.com

17 sites in 3 countries

Poland10 sites, 10 recruiting

  • NZOZ Bif-Med. s.c

    Bytom, 41-902

    Hanna Mastalerz, MD, +48508270636, hannamastalerz@wp.pl

    Hanna Mastalerz, MD

    Recruiting

  • Vita Longa Sp. z o.o.

    Katowice, 40-748

    Barbara Stasiuk, MD, +48797947052, barbara.stasiuk@researchsolutions.pl

    Barbara Stasiuk, MD

    Recruiting

  • Centrum Medyczne PLEJADY

    Krakow, 30-363

    Alicja Włoch, MD, +48501150912, alawloch@interia.pl

    Alicja Włoch, MD

    Not yet recruiting

  • Medyczne Centrum Hetmańska

    Poznan, 60-218

    Piotr Leszczyński, MD, +48698806606, piotr.leszczynski@centrum-hetmanska.pl

    Piotr Leszczyński, MD

    Recruiting

  • Reumedika sp. z o.o.

    Poznan, 60-446

    Wieslawa Porawska, MD, +48618866866, wporawska@reumedika.pl

    Wieslawa Porawska, MD

    Recruiting

  • DC-MED Michal Kowalski S.K. Radom

    Radom, 26-610

    Tomasz Romaniuk, MD, +48601495963, t.romaniuk@dc-med.pl

    Tomasz Romaniuk, MD

    Not yet recruiting

  • DC-MED Michal Kowalski S.K. Swidnica

    Swidnica, 58-100

    Paweł Michalec, MD, +48533599794, p.michalec@dc-med.pl

    Paweł Michalec, MD

    Recruiting

  • Etg Justmed

    Warsaw, 01-869

    Wojciech Zakiewicz, MD, +48606328528, w.zakiewicz@etg-network.com

    Wojciech Zakiewicz, MD

    Recruiting

  • Etg Warszawa

    Warsaw, 02-677

    Radoslaw Gorski, MD, +48575000243, r.gorski@etg-network.com

    Radoslaw Gorski, MD

    Recruiting

  • Migre Polskie Centrum

    Wroclaw, 52-210

    Marta Wasilewska, MD, +48880299924, marta.wasilewska@migre.pl

    Marta Wasilewska, MD

    Recruiting

Other trials in Poland

United States4 sites, 4 recruiting

  • Future Medical Research

    Longwood, Florida, 32750

    Mayra Abreu, MD, +13212256060, mayra.abreu@futuremedres.com

    Mayra Abreu, MD

    Recruiting

  • South Florida Research Phase I-IV

    Miami, Florida, 33166

    Eduardo Viera, MD, +3054180847, eviera@southfloridatrials.com

    Eduardo Viera, MD

    Recruiting

  • DelRicht Research @ Touro Medical Center

    New Orleans, Louisiana, 70115

    Patrick Dennis, MD, +115043362667, pdennis@delricht.com

    Patrick Dennis, MD

    Recruiting

  • Oakland Medical Research

    Troy, Michigan, 48085

    Jay Sandberg, MD, +12486877412, jsandberg@oaklandmedicalresearch.com

    Jay Sandberg, MD

    Recruiting

Other trials in United States

Denmark3 sites, 3 recruiting

  • Sanos Clinic Gandrup

    Gandrup, 9362

    Søren R Bro, MD, +4573708220, sbr@sanosclinic.com

    Søren R Bro, MD

    Recruiting

  • Sanos Clinic Herlev

    Herlev, 2730

    Linda Bracher, MD, +4573708229, lbr@sanosclinic.com

    Linda Bracher, MD

    Recruiting

  • Sanos Clinic Vejle

    Vejle, 7100

    Sidsel Boll, MD, +4573708232, sib@sanosclinic.com

    Sidsel Boll, MD

    Recruiting

Other trials in Denmark

About this study

Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).

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.

The main goal of this Phase IIb clinical trial is to evaluate the efficacy of intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA), in comparison to Placebo (a look-alike substance that contains no drug). Participants will be randomized 1:1 to Allocetra or Placebo. Treatment consists of a total of three ultrasound-guided intra-articular (IA) injections (Days 0, 14, 28). Follow-up will continue for 12 months.

Being tested
Allocetra, Placebo
Keywords
Knee, Osteoarthritis, Allocetra
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AllocetraDrug

    Allocetra 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 groups in NCT07580716
Study groupRoleWhat they receive
AllocetraExperimentalThree intra-articular injections of Allocetra at a selected dose, into the index knee.
Receives: Drug: Allocetra
PlaceboPlacebo comparatorThree intra-articular injections of placebo into the index knee.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months

    The change from baseline of the WOMAC Pain score at 3 months between Allocetra and Placebo. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).

    Measured: 3 months.

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score at 3 months

    The change from baseline for the WOMAC Function score at 3 months between Allocetra and Placebo. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).

    Measured: 3 months.

  3. Primary Safety Endpoint

    Incidence and severity of Adverse Events (AEs) up to 6 months. AE incidence will be represented as % per study group and AE severity will be represented as mild, moderate or severe.

    Measured: Day 0 to 6 months.

Secondary outcomes (6)

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score

    The change from baseline of the WOMAC Pain score at 6 months. Total Pain score ranges from 0 (No pain) to 50 (Extreme pain).

    Measured: 6 months.

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function score

    The change from baseline of the WOMAC Function score at 6 months. Total Function score ranges from 0 (No difficulty) to 170 (Extreme difficulty).

    Measured: 6 months.

  3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total score

    The change from baseline for the WOMAC Total score at 3 and 6 months. Total score ranges from 0 to 240 when higher score means worse outcomes.

    Measured: 3 months, 6 months.

  4. Average Daily Pain Numerical Rating Scale (ADP-NRS)

    The change from baseline of the Average Daily Pain Numerical Rating Scale (ADP-NRS) at 3 and 6 months. ADP-NRS score ranges from 0 (No pain) to 10 (Worst imaginable pain).

    Measured: 3 months, 6 months.

  5. Outcome Measures in Rheumatology and Osteoarthritis Research Society International (OMERACT-OARSI) score

    Treatment responders at 3 and 6 months according to the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) criteria. OMERACT-OARSI score will be represented as % when higher scores means a better outcome.

    Measured: 3 months, 6 months.

  6. Euro Quality of Life-5-Dimension (EQ-5D) index scores

    Change from baseline in Euro Quality of Life-5-Dimension (EQ-5D) index scores at 3 and 6 months. EQ-5D index scores in composed of an index value which range from 0 to 1 and EQ VAS score which range from 0 to 100. In both a higher score means better outcomes.

    Measured: 3 months, 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 May 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580716
Sponsor's protocol ID
ENX-CL-05-002
Status last verified
Oct 2026
First submitted
23 Apr 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allocetra in people with Primary Knee Osteoarthritis, run by Enlivex Therapeutics Ltd. at 17 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 9 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Poland, United States, Denmark. 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 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?

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 Lior Binder (+972-54-8054599, lior@enlivex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score at 3 months (time frame: 3 months.). The study lists 3 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 NCT07580716.

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 Oct 2026.

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