NCT07580716

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_2

Timeline
22mo left

Started May 2026

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Apr 2028

First Submitted

Initial submission to the registry

April 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

April 23, 2026

Last Update Submit

May 17, 2026

Conditions

Primary Knee Osteoarthritis

Keywords

KneeOsteoarthritisAllocetra

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

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

    6 months.

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

    6 months.

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

    3 months, 6 months.

  • Average Daily Pain Numerical Rating Scale (ADP-NRS)

    3 months, 6 months.

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

    3 months, 6 months.

  • +1 more secondary outcomes

Study Arms (2)

Allocetra

EXPERIMENTAL

Three intra-articular injections of Allocetra at a selected dose, into the index knee.

Drug: Allocetra

Placebo

PLACEBO COMPARATOR

Three intra-articular injections of placebo into the index knee.

Other: Placebo

Interventions

PlaceboOTHER

The control used in this study will be placebo. Placebo solution containing all excipients except for the Allocetra cells.

Placebo
AllocetraDRUG

Allocetra is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, induced to an apoptotic stable state.

Allocetra

Eligibility Criteria

Age64 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Future Medical Research

Longwood, Florida, 32750, United States

RECRUITING

South Florida Research Phase I-IV

Miami, Florida, 33166, United States

NOT YET RECRUITING

DelRicht Research @ Touro Medical Center

New Orleans, Louisiana, 70115, United States

RECRUITING

Oakland Medical Research

Troy, Michigan, 48085, United States

NOT YET RECRUITING

Sanos Clinic Gandrup

Gandrup, 9362, Denmark

NOT YET RECRUITING

Sanos Clinic Herlev

Herlev, 2730, Denmark

NOT YET RECRUITING

Sanos Clinic Vejle

Vejle, 7100, Denmark

NOT YET RECRUITING

NZOZ Bif-Med. s.c

Bytom, 41-902, Poland

NOT YET RECRUITING

Vita Longa Sp. z o.o.

Katowice, 40-748, Poland

NOT YET RECRUITING

Centrum Medyczne PLEJADY

Krakow, 30-363, Poland

NOT YET RECRUITING

Medyczne Centrum Hetmańska

Poznan, 60-218, Poland

NOT YET RECRUITING

Reumedika sp. z o.o.

Poznan, 60-446, Poland

NOT YET RECRUITING

DC-MED Michal Kowalski S.K. Radom

Radom, 26-610, Poland

NOT YET RECRUITING

DC-MED Michal Kowalski S.K. Swidnica

Swidnica, 58-100, Poland

NOT YET RECRUITING

Etg Justmed

Warsaw, 01-696, Poland

NOT YET RECRUITING

Etg Warszawa

Warsaw, 02-677, Poland

NOT YET RECRUITING

Migre Polskie Centrum

Wroclaw, 52-210, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lital Weinfeld Bergman

    Senior Director of Clinical Operations

    STUDY DIRECTOR

Central Study Contacts

Lior Binder

CONTACT

+972-54-8054599lior@enlivex.com

Lital Weinfeld Bergman

CONTACT

lital@enlivex.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

DK(3)PL(10)US(4)