A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis
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).
⁃ Participants must meet all of the inclusion criteria 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 contraception from randomization and for 90 days after last dose.