Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

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).

Study Overview

• Status: Recruiting
• Conditions: Primary Knee Osteoarthritis
• Intervention / Treatment: Other: Placebo; Drug: Allocetra

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.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lior Binder; Phone Number: +972-54-8054599; Email: lior@enlivex.com
• Study Contact Backup: Name: Lital Weinfeld Bergman; Email: lital@enlivex.com

Study Locations

• Denmark
  • Gandrup, Denmark, 9362
    • Not yet recruiting
    • Sanos Clinic Gandrup
    • Contact: Søren R Bro, MD; Phone Number: +4573708220; Email: sbr@sanosclinic.com
    • Principal Investigator: Søren R Bro, MD
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Sanos Clinic Herlev
    • Contact: Linda Bracher, MD; Phone Number: +4573708229; Email: lbr@sanosclinic.com
    • Principal Investigator: Linda Bracher, MD
  • Vejle, Denmark, 7100
    • Not yet recruiting
    • Sanos Clinic Vejle
    • Contact: Sidsel Boll, MD; Phone Number: +4573708232; Email: sib@sanosclinic.com
    • Principal Investigator: Sidsel Boll, MD
• Poland
  • Bytom, Poland, 41-902
    • Not yet recruiting
    • NZOZ Bif-Med. s.c
    • Contact: Hanna Mastalerz, MD; Phone Number: +48508270636; Email: hannamastalerz@wp.pl
    • Principal Investigator: Hanna Mastalerz, MD
  • Katowice, Poland, 40-748
    • Not yet recruiting
    • Vita Longa Sp. z o.o.
    • Contact: Barbara Stasiuk, MD; Phone Number: +48797947052; Email: barbara.stasiuk@researchsolutions.pl
    • Principal Investigator: Barbara Stasiuk, MD
  • Krakow, Poland, 30-363
    • Not yet recruiting
    • Centrum Medyczne Plejady
    • Contact: Alicja Włoch, MD; Phone Number: +48501150912; Email: alawloch@interia.pl
    • Principal Investigator: Alicja Włoch, MD
  • Poznan, Poland, 60-218
    • Not yet recruiting
    • Medyczne Centrum Hetmańska
    • Contact: Piotr Leszczyński, MD; Phone Number: +48698806606; Email: piotr.leszczynski@centrum-hetmanska.pl
    • Principal Investigator: Piotr Leszczyński, MD
  • Poznan, Poland, 60-446
    • Not yet recruiting
    • Reumedika sp. z o.o.
    • Contact: Wieslawa Porawska, MD; Phone Number: +48618866866; Email: wporawska@reumedika.pl
    • Principal Investigator: Wieslawa Porawska, MD
  • Radom, Poland, 26-610
    • Not yet recruiting
    • DC-MED Michal Kowalski S.K. Radom
    • Contact: Tomasz Romaniuk, MD; Phone Number: +48601495963; Email: t.romaniuk@dc-med.pl
    • Principal Investigator: Tomasz Romaniuk, MD
  • Swidnica, Poland, 58-100
    • Not yet recruiting
    • DC-MED Michal Kowalski S.K. Swidnica
    • Contact: Paweł Michalec, MD; Phone Number: +48533599794; Email: p.michalec@dc-med.pl
    • Principal Investigator: Paweł Michalec, MD
  • Warsaw, Poland, 02-677
    • Not yet recruiting
    • ETG Warszawa
    • Contact: Radoslaw Gorski, MD; Phone Number: +48575000243; Email: r.gorski@etg-network.com
    • Principal Investigator: Radoslaw Gorski, MD
  • Warsaw, Poland, 01-696
    • Not yet recruiting
    • Etg Justmed
    • Contact: Wojciech Zakiewicz, MD; Phone Number: +48606328528; Email: w.zakiewicz@etg-network.com
    • Principal Investigator: Wojciech Zakiewicz, MD
  • Wroclaw, Poland, 52-210
    • Not yet recruiting
    • Migre Polskie Centrum
    • Contact: Marta Wasilewska, MD; Phone Number: +48880299924; Email: marta.wasilewska@migre.pl
    • Principal Investigator: Marta Wasilewska, MD
• United States
  • Florida
    • Longwood, Florida, United States, 32750
      • Recruiting
      • Future Medical Research
      • Contact: Mayra Abreu, MD; Phone Number: +13212256060; Email: mayra.abreu@futuremedres.com
      • Principal Investigator: Mayra Abreu, MD
    • Miami, Florida, United States, 33166
      • Not yet recruiting
      • South Florida Research Phase I-IV
      • Contact: Eduardo Viera, MD; Phone Number: +3054180847; Email: eviera@southfloridatrials.com
      • Principal Investigator: Eduardo Viera, MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • DelRicht Research @ Touro Medical Center
      • Principal Investigator: Patrick Dennis, MD
      • Contact: Patrick Dennis, MD; Phone Number: +115043362667; Email: pdennis@delricht.com
  • Michigan
    • Troy, Michigan, United States, 48085
      • Not yet recruiting
      • Oakland Medical Research
      • Contact: Jay Sandberg, MD; Phone Number: +12486877412; Email: jsandberg@oaklandmedicalresearch.com
      • Principal Investigator: Jay Sandberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to be eligible for the study:

1. Age 64 years or above.
2. Diagnosis of primary femorotibial knee OA.
3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
5. Index knee pain assessed during the screening period and following wash-out of pain medications.
6. Willingness to abstain from prohibited medications/treatments during the trial.
7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
8. 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.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Severe or end-stage osteoarthritis of the index knee.
2. Clinically significant structural abnormalities or instability of the index knee.
3. Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
4. Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
5. Any known history of inflammatory arthropathy or crystal-deposition disease.
6. Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
7. Clinically significant widespread pain syndromes.
8. Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
9. Body Mass Index (BMI) >40 kg/m²
10. Use of medications that may interfere with pain assessment or study outcomes.
11. Known coagulopathy or use of anticoagulant/antiaggregant medication.
12. Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allocetra; Three intra-articular injections of Allocetra at a selected dose, into the index knee.	Drug: Allocetra; Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.
Placebo Comparator: Placebo; Three intra-articular injections of placebo into the index knee.	Other: Placebo; The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months.
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).	3 months.
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.	Day 0 to 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months.
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).	6 months.
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.	3 months, 6 months.
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).	3 months, 6 months.
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.	3 months, 6 months.
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.	3 months, 6 months.

Collaborators and Investigators

• Sponsor: Enlivex Therapeutics Ltd.
• Collaborators: Nordic Bioscience Clinical Development (NBCD)
• Investigators: Study Director: Lital Weinfeld Bergman, Senior Director of Clinical Operations

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Allocetra
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: ENX-CL-05-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No