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New treatment option for Primary Knee Osteoarthritis
Official title Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07580716
What this study is testing
What is Allocetra?
Allocetra is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for primary knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to evaluate intra-articular (IA) injections of Allocetra in participants with moderate-to-severe age related symptomatic primary knee osteoarthritis (OA).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 64 and older
You may be able to join if
- Participants must meet all of the listed below to be eligible for the study:
- Age 64 years or above.
- Diagnosis of primary femorotibial knee OA.
- Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
- Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
You likely can't join if
- Participants will be excluded from the study if they meet any of the following criteria:
- Severe or end-stage osteoarthritis of the index knee.
- Clinically significant structural abnormalities or instability of the index knee.
- Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
- Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
- Any known history of inflammatory arthropathy or crystal-deposition disease.
See the full eligibility criteria
- Participants must meet all of the listed below to be eligible for the study:
- Age 64 years or above.
- Diagnosis of primary femorotibial knee OA.
- Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
- Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
- Index knee pain assessed during the screening period and following wash-out of pain medications.
- Willingness to abstain from prohibited medications/treatments during the trial.
- Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- 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...
- Participants will be excluded from the study if they meet any of the following criteria:
- Severe or end-stage osteoarthritis of the index knee.
- Clinically significant structural abnormalities or instability of the index knee.
- Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
- Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
- Any known history of inflammatory arthropathy or crystal-deposition disease.
- Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
- Clinically significant widespread pain syndromes.
- Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
- Body Mass Index (BMI) \>40 kg/m²
- Use of medications that may interfere with pain assessment or study outcomes.
- Known coagulopathy or use of anticoagulant/antiaggregant medication.
- Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.
The study team makes the final eligibility decision.
Where it's taking place
- Longwood, Florida, United States
- Miami, Florida, United States
- New Orleans, Louisiana, United States
- Troy, Michigan, United States
- Gandrup, Denmark
- Herlev, Denmark
- Vejle, Denmark
- Bytom, Poland
- Katowice, Poland
- Krakow, Poland
- Poznan, Poland
- Radom, Poland
- Swidnica, Poland
- Warsaw, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 64 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Longwood, Florida, United States; Miami, Florida, United States; New Orleans, Louisiana, United States; Troy, Michigan, United States; Gandrup, Denmark; Herlev, Denmark and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.