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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208241
• Other study ID #: 189-22
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 12, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Kaplan Medical Center
• Contact: Shiran Rogoff
• Phone: +972526804062
• Email: shiranro1[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Accetable 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Re?ovot

Sponsors (2)

Lead Sponsor	Collaborator
Amir Oron	Enlivex Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of Allocetra-OTS- Pain mitigation as measured by Visual Analog Scale tool.	To assess the efficacy of Allocetra-OTS. Secondary endpoints for efficacy will be measured in terms of: • Pain mitigation as measured by VAS (Visual Analog Scale) tool in a range of 0-10 points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	6 months
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) response change along study period (questionnaires aimed at assessing arthritis related function ).; The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.; Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.	6 month
Secondary	SF-36 questionnaire response change along study period	SF-36 questionnaire response change along study period (questionnaires aimed at assessing quality of life,).	6 month