Intra-Articular Allocetra for Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase IIb, multicenter, randomized, double-blind study compares three ultrasound-guided intra-articular Allocetra injections to placebo in adults aged 64 and older with radiographically confirmed primary knee OA who have not adequately responded to at least two OA therapies. Participants receive injections on Days 0, 14, and 28 and are followed for 12 months to assess pain and function. Allocetra consists of modified allogeneic peripheral blood mononuclear cells designed to promote cartilage-friendly inflammation resolution. The trial seeks to determine if Allocetra can reduce knee pain and improve function compared with placebo. Enrollment occurs at selected sites in Florida and Louisiana.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to be eligible for the study:

1. Age 64 years or above.
2. Diagnosis of primary femorotibial knee OA.
3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
4. Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
5. Index knee pain assessed during the screening period and following wash-out of pain medications.
6. Willingness to abstain from prohibited medications/treatments during the trial.
7. Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
8. Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Severe or end-stage osteoarthritis of the index knee.
2. Clinically significant structural abnormalities or instability of the index knee.
3. Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
4. Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
5. Any known history of inflammatory arthropathy or crystal-deposition disease.
6. Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
7. Clinically significant widespread pain syndromes.
8. Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
9. Body Mass Index (BMI) \>40 kg/m²
10. Use of medications that may interfere with pain assessment or study outcomes.
11. Known coagulopathy or use of anticoagulant/antiaggregant medication.
12. Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.

Where it's running

• Future Medical Research
  Longwood, Florida, United States Recruiting
• South Florida Research Phase I-IV
  Miami, Florida, United States Recruiting
• DelRicht Research @ Touro Medical Center
  New Orleans, Louisiana, United States Recruiting
• Oakland Medical Research
  Troy, Michigan, United States Recruiting
• Sanos Clinic Gandrup
  Gandrup, Denmark Recruiting
• Sanos Clinic Herlev
  Herlev, Denmark Recruiting

Study contacts

• Study coordinator: Lior Binder
• Email: lior@enlivex.com
• Phone: +972-54-8054599

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cold and compression after total knee replacement

  This tests whether using a cold-compression device after total knee replacement reduces pain compared with standard care for adults with primary osteoarthritis.

  Recruiting Ochsner Health System · New Orleans, Louisiana · NCT07023185

• Effects of virtual reality on walking in adults with knee osteoarthritis

  This study tests how immersive virtual reality environments—designed to feel safe or to provoke fear—affect walking and worry about movement in adults 50 and older with knee osteoarthritis and in healthy peers.

  Recruiting University of Primorska · Vilnius and 1 other locations · NCT07920120

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty

  This study tests whether higher burden of preoperative multimorbidity affects functional recovery after knee replacement in adults with knee osteoarthritis.

  Recruiting Balikesir Ataturk City Hospital · Balıkesir · NCT07882316

• Cartilage biomarker response to acute loading in knee OA by antiresorptive treatment status

  Researchers will test whether a 30-minute treadmill walk changes cartilage biomarkers in postmenopausal women with knee osteoarthritis, comparing those on denosumab, bisphosphonates, and those not on antiresorptives.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07881861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.