Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety

NCT06208241 | Active Not Recruiting Early Phase 1

• 1 other identifier: 189-22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess safety and possible efficacy of Allocetra-OTS in end-stage knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events and Serious adverse events following Allocetra-OTS injection

  The safety and tolerability endpoint evaluates the incidence and severity of complications following intraarticular injection of Allocetra-OTS: * Injection-related reactions occurring during Allocetra-OTS injection, including injection interruption/discontinuation. * Treatment-emergent adverse events following Allocetra-OTS injection. * Treatment-emergent serious adverse events. * Adverse events or serious adverse events related to the use of Allocetra-OTS as an intraarticular injection material. * Safety assessments beyond 1 month following injection will focus on events that are at least possibly related to Allocetra-OTS treatment.

  6 months

Secondary Outcomes (3)

• Efficacy of Allocetra-OTS- Pain mitigation as measured by Visual Analog Scale tool.

  6 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period

  6 month

• SF-36 questionnaire response change along study period

  6 month

Study Arms (1)

Allocetra-OTS

EXPERIMENTAL

Two IA dose of Allocetra-OTS cells in suspension

Drug: Allocetra-OTS

Interventions

Allocetra-OTS DRUG

Allocetra-OTS is a cell-based therapy consisting of non-HLA-matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state and suspended in a solution containing DMSO.

Allocetra-OTS

Eligibility Criteria

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

You may qualify if:

• Age 18 or older.
• Diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery.
• X-ray positive for knee osteoarthritis.
• Pain and functional disability from osteoarthritis.
• Acceptable blood workup results (CBC, electrolytes, kidney and liver function) from up to three months before treatment.
• Mentally and physically able to fully comply with the study protocol.
• Signed Informed Consent form.

You may not qualify if:

• Evidence of active local infection in the vicinity of the knee joint.
• Previous surgery of total or partial knee replacement in the injected knee.
• Patients unable to provide informed consent due to language barrier or mental status.
• Patients with a major medical condition that would affect quality of life and influence the results of the study.
• Patients unwilling to be followed for the duration of the study.
• Acute infection requiring intravenous antibiotics at the time of screening.
• Other limb pain of unknown etiology.
• Pain in the limb clinically assessed to arise from an origin which is not the affected knee joint.
• Known neurological disease or rheumatic condition other than osteoarthritis.
• Bleeding disorders.
• Known cognitive disorder.
• Concurrent participation in any other clinical study. Participation in an interventional investigational study within 30 days prior to enrollment.
• Physician objection.
• Positive pregnancy test.

Sponsors & Collaborators

• Amir Oron: lead
• Enlivex Therapeutics Ltd.: collaborator

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Amir Oron, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: January 17, 2024
• Study Start: July 12, 2023
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IL (1)