Study of Intra-articular Allocetra in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2026-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Run-in phase followed by randomization phase

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Safety run-in phase - Allocetra increasing dose

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.

Group Type OTHER

Allocetra

Intervention Type 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 - Placebo.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Randomization phase - Allocetra

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

Group Type EXPERIMENTAL

Allocetra

Intervention Type DRUG

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

Interventions

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Allocetra

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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 and following wash-out of pain medications
5. Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy.
6. Willing to abstain from other intra-articular treatments and adhere to the protocol restrictions for concomitant medications and therapies during the study.
7. 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.

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 limited to, 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 6 months
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 COVID syndrome.
15. Known coagulopathy, or use of anticoagulation medication or antiaggregant medication;.
16. certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No