Study of Intra-articular Allocetra in Knee Osteoarthritis

Last updated: June 26, 2024
Sponsor: Enlivex Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Osteoarthritis

Treatment

Placebo

Allocetra

Clinical Study ID

NCT06233474
ENX-CL-05-001
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 45 - 80 years.

  2. Chronic osteoarthritis of index knee with knee-related joint pain

  3. Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee.

  4. Knee pain assessed daily over a period of 7 days during the screening period andfollowing wash-out of pain medications

  5. Patients with chronic knee pain for at least 3 months who have failed to respondadequately to conventional therapy.

  6. Willing to abstain from other intra-articular treatments and adhere to the protocolrestrictions for concomitant medications and therapies during the study.

  7. Women of childbearing potential and all men must agree to use 2 methods of anadequate contraception prior to study entry and for the duration of studyparticipation through 4 weeks following IP administration.

Exclusion

Exclusion Criteria:

  1. Wheelchair bound.

  2. Immunosuppressive therapy

  3. Any known current or prior tumor of the index knee.

  4. Any known history or current intra-articular or osseous infection of the index knee.

  5. Any evidence of clinically significant active infection

  6. Any known history of inflammatory arthropathy or crystal-deposition arthropathy

  7. Any known severe systemic cartilage and/or bone disorder, such as, but not limitedto, chondrodysplasia, osteogenesis imperfecta.

  8. Body Mass Index (BMI) >40.

  9. Any major surgical cartilage treatment within 6 months

  10. Any ligamentous repair or malalignment correction in the index knee within 6 months

  11. Major injury to the index knee, such as torn ligament or severe sprain within 6months

  12. Clinically relevant knee instability of the index knee

  13. Severe hip osteoarthritis ipsilateral to the index knee.

  14. Clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVIDsyndrome.

  15. Known coagulopathy, or use of anticoagulation medication or antiaggregantmedication;.

  16. certain tumors, severe cardiac, respiratory or hematologic diseases as defined inthe protocol

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
January 26, 2024
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • Sanos Clinic Nordjylland

    Gandrup, 9362
    Denmark

    Site Not Available

  • Sanos Clinic Herlev

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Sanos Clinic Syddanmark

    Vejle, 7100
    Denmark

    Site Not Available

  • Haemek Medical Center

    Afula,
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 7651211
    Israel

    Active - Recruiting

  • Beilinson Medical Center

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Hasharon Medical Center

    Petach Tikva, 4937211
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5266202
    Israel

    Active - Recruiting

  • Kaplan Medical Center

    Reẖovot, 7661041
    Israel

    Active - Recruiting

  • Ichilov - Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

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