Study of Intra-articular Allocetra in Knee Osteoarthritis

NCT06233474 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: ENX-CL-05-001
• Study Type: interventional
• Target: 160
• Locations: 3 countries
• Sites: 12

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

  7 months following Day 0

Secondary Outcomes (3)

• Weekly average of knee pain.

  4 months and 7 months following Day 0.

• Change from baseline in WOMAC total score.

  4 months, 7 months and 13 months following Day 0.

• Change in quality of life- Euro Quality of Life-5-dimension (EQ-5D) questionnaire

  4 months, 7 months and 13 months following Day 0.

Study Arms (3)

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.

Drug: Allocetra

Randomization phase - Placebo.

PLACEBO COMPARATOR

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

Other: Placebo

Randomization phase - Allocetra

EXPERIMENTAL

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

Drug: Allocetra

Interventions

Allocetra DRUG

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

Randomization phase - Allocetra; Safety run-in phase - Allocetra increasing dose

Placebo OTHER

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

Randomization phase - Placebo.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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;.

Sponsors & Collaborators

• Nordic Bioscience Clinical Development (NBCD): collaborator
• Enlivex Therapeutics Ltd.: lead

Study Sites (12)

Sanos Clinic Nordjylland

Gandrup, 9362, Denmark

Location

Sanos Clinic Herlev

Herlev, 2730, Denmark

Location

Sanos Clinic Syddanmark

Vejle, 7100, Denmark

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Rambam Medical Center

Haifa, 7651211, Israel

Location

Hasharon Medical Center

Petah Tikva, 4937211, Israel

Location

Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

Kaplan Medical Center

Rehovot, 7661041, Israel

Location

Ichilov - Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

IMSP Institutul de Cardiologie

Chisinau, 2025, Moldova

Location

Spitalul Clininc Republican "T. Mosneaga"

Chisinau, 2025, Moldova

Location

IMSP Sptalul Clinic Municipal "Sfanta Treime"

Chisinau, 2068, Moldova

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lital Weinfeld-Bergman

  Senior Director of Clinical Operations

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Run-in phase followed by randomization phase

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: January 26, 2024
• Primary Completion: March 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

IL (6); DK (3); MO (3)