A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
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⁃ Subjects eligible for this clinical study must fulfill all of the following:
• Age 40 years or older.
• Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.
• Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
• X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
• Blood tests from up to three months before treatment within protocol-defined limits.
Locations
Other Locations
Israel
Kaplan Medical Center
RECRUITING
Rehovot
Contact Information
Primary
Amir Oron, MD
amiroro@clalit.org.il
+972-54-2427072
Backup
Shiran Rogoff
Shiranro1@clalit.org.il
+972-52-6804062
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2025-11
Participants
Target number of participants: 46
Treatments
Other: Safety run-in phase - Allocetra increasing dose
A dose escalation phase to characterize the safety of Allocetra injection to the 1st CMC joint in the target thumb in different doses and select the dose for the randomized phase.
Active_comparator: Randomization phase - Allocetra
Injection of Allocetra to the 1st CMC joint in the target thumb.
Placebo_comparator: Randomization phase - Placebo
Injection of placebo to the 1st CMC joint in the target thumb.
Related Therapeutic Areas
Sponsors
Leads: Kaplan Medical Center