drugset / Trial / NCT05234489
Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee
Phase 1
Unknown
10 enrolled
Thomas Klootwyk, MD
KLM Solutions, LLC · collabSignature Biologics, LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is a Phase 1 trial. The overall objective is to evaluate the safety and potential efficacy of a specific type of umbilical cord tissue-derived product (SIG001), which, other than a change in cryopreservation medium to render it compatible with cGMP, is similar to the reported real-world experience from 2 clinics on 135 knees.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2023-06
- Completion
- 2023-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Signature Cord Prime | Unknown | 75 mg | Other |
| Comparator | Signature Cord Prime | Unknown | 150 mg | Other |