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Study to Assess Signature Cord Product in Patients With Symptomatic OA of the Knee

NCT05234489 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-02-10

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

Signature Cord Prime

Low dose - Subjects will receive SIG001 (75 mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate. High dose - Subjects will receive SIG001 (150mg) which will be diluted to a total of 4 ml volume with Ringer's Lactate.

Sponsors & Collaborators

  • Signature Biologics, LLC

    collaborator UNKNOWN

  • KLM Solutions, LLC

    collaborator UNKNOWN

  • Thomas Klootwyk, MD

    lead OTHER

Principal Investigators

  • Thomas Klootwyk, MD · Forte Sports Medicine and Orthopedics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234489 on ClinicalTrials.gov