Signature Cord Prime (SIG001)
/ Arugula Sci
- LARVOL DELTA
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January 04, 2023
Arugula Sciences Announces Company Launch with FDA Phase 1 Approval for Osteoarthritis Therapy
(Businesswire)
- "Arugula Sciences...announced that it has, in collaboration with its clinical partners, advanced its first therapeutic product, Signature Cord Prime™ (SIG001), with FDA approval for a Phase 1 clinical trial (NCT05234489) in the US. This Phase 1 study is an open-label, dose-ranging assessment of safety, tolerability, preliminary efficacy, and dose effects in patients with symptomatic osteoarthritis of the knee. Signature Cord Prime™ is the first human umbilical cord allograft product to receive FDA approval to be studied as an intra-articular injection to treat the signs and symptoms of knee osteoarthritis."
Licensing / partnership • New P1 trial • CNS Disorders • Immunology • Osteoarthritis • Pain
February 10, 2022
Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee
(clinicaltrials.gov)
- P1 | N=10 | Not yet recruiting | Sponsor: Thomas Klootwyk, MD
New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology
February 16, 2021
Signature Cord Prime Receives Investigational New Drug (IND) Approval from FDA for Phase 1 Study in Patients with Symptomatic Osteoarthritis of the Knee.
(PRNewswire)
- "Signature Biologics...today announced that the U.S. Food and Drug Administration (FDA) has approved an IND Application to proceed with the study of Signature Cord Prime™ in patients with symptomatic osteoarthritis (OA) of the knee with our Principal Investigator...Signature Biologics applied for the IND for Signature Cord Prime™ to begin clinical study of the product, working towards a full Biologics Licensing Application (BLA) with FDA's Center for Biologics Evaluation and Research (CBER)."
IND • Osteoarthritis • Pain
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