270 Participants NeededMy employer runs this trial

Allocetra for Knee Arthritis

Recruiting at 16 trial locations
LB
LW
Overseen ByLital Weinfeld Bergman
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Allocetra, an experimental therapy, to determine its effectiveness for knee osteoarthritis (OA), a condition causing joint pain and stiffness. The trial compares Allocetra injections directly into the knee with placebo injections to evaluate which is more effective. Individuals with moderate to severe knee OA, who have tried at least two other treatments without success and experience knee pain, might be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires participants to stop taking certain pain medications before the screening period and to avoid certain medications during the trial. However, the specific medications you need to stop are not detailed in the information provided.

Is there any evidence suggesting that Allocetra is likely to be safe for humans?

Research has shown that Allocetra is safe for treating knee osteoarthritis. In past studies, including one with multiple injections, participants generally tolerated the treatment well. No serious side effects occurred during or after the treatment.

Participants in earlier trials managed the treatment without major issues. While some side effects might occur, they were not serious enough to halt the study. Overall, current evidence suggests Allocetra is a safe option.12345

Why do researchers think this study treatment might be promising for knee arthritis?

Allocetra is unique because it represents a novel approach to treating knee arthritis with its focus on modulating the immune response. Unlike standard treatments like NSAIDs or corticosteroids, which mainly address pain and inflammation, Allocetra works by targeting the root cause of inflammation through its cellular mechanism. This treatment involves intra-articular injections directly into the knee, potentially offering more localized and effective relief by harnessing the body's own immune system to promote healing. Researchers are excited about Allocetra because it could provide longer-lasting benefits with fewer side effects compared to current therapies.

What evidence suggests that Allocetra might be an effective treatment for knee osteoarthritis?

Research has shown that Allocetra, which participants in this trial may receive, may help treat knee osteoarthritis (OA). In studies, patients using Allocetra reported a 42% improvement in knee joint function, along with noticeable reductions in stiffness and pain. These findings suggest that Allocetra could ease daily activities for people with knee OA. Additionally, data indicates a 47% improvement in stiffness and function scores, highlighting its potential as an effective treatment. Overall, early results are promising, suggesting that Allocetra might provide real relief for those dealing with knee osteoarthritis.12367

Who Is on the Research Team?

LW

Lital Weinfeld Bergman

Principal Investigator

Senior Director of Clinical Operations

Are You a Good Fit for This Trial?

This trial is for people aged 64 or older with moderate-to-severe knee osteoarthritis confirmed by X-ray, who have not improved after trying at least two other treatments. Participants must be able to stop certain medications and meet specific reproductive health requirements.

Inclusion Criteria

My knee X-ray shows moderate osteoarthritis.
I have not improved with at least two osteoarthritis treatments.
I have knee pain that was checked after stopping pain medications.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three ultrasound-guided intra-articular injections of Allocetra or placebo on Days 0, 14, and 28

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Allocetra

Trial Overview

The study compares injections of Allocetra directly into the knee joint versus placebo (inactive injection) in patients with knee osteoarthritis. It is randomized, double-blind, and placebo-controlled, meaning neither doctors nor participants know which treatment they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: AllocetraExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enlivex Therapeutics Ltd.

Lead Sponsor

Trials
8
Recruited
390+

Nordic Bioscience Clinical Development (NBCD)

Collaborator

Trials
3
Recruited
1,100+

Citations

Enlivex Announces Positive Topline Data From Multi ...

We believe these results provide clear indication that Allocetra™ has the potential to become a novel, safe and effective treatment for knee ...

Study of Intra-articular Allocetra in Knee Osteoarthritis

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 ...

Enlivex Reports Positive Interim Results from Allocetra Trial ...

- Average knee joint function, on a scale from 0 to 10, improved from 4.7 to 2.83, a 42% enhancement (p<0.0008). - Average knee joint stiffness ...

Use of Allocetra-OTS in End Stage Knee Osteoarthritis

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

Enlivex advances lead cell therapy to Phase IIb in ...

Allocetra also significantly improved WOMAC stiffness and function change, as well as pain and function change scores – boosting these by 47% ...

Phase I/II Clinical Trial of Allocetra TM Cell Therapy for ...

Conclusions: A characterization of safety of AllocetraTM IA injections for knee OA indicates a favorable safety profile with good compliance to repeat ...

Study on the Safety of Allocetra for Patients with Knee ...

The purpose of the study is to evaluate the safety and tolerability of Allocetra-OTS when injected directly into the knee joint. The study will compare the ...