Use of Allocetra-OTS in End Stage 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

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allocetra-OTS

Two IA dose of Allocetra-OTS cells in suspension

Group Type EXPERIMENTAL

Allocetra-OTS

Intervention Type 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.

Interventions

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Allocetra-OTS

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No