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A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis

NCT02188771 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-04-27

No results posted yet for this study

Summary

This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial designed to assess the safety and tolerability of single intra-articular injection of RegenoGel-SP for the treatment of OA.

RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The viscoelastic properties resulting from the combination of these two natural macromolecules is further enhanced by joint surface associated factors to generate a viscoelastic gel with superior stability and mechanical integrity.

Conditions

Interventions

DEVICE

intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)

Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA

Sponsors & Collaborators

  • ProCore Ltd.

    lead INDUSTRY

Principal Investigators

  • Gabrilet Agar, Dr · Assaf Harofe Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Israel

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Entities

Diseases

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 NCT02188771 on ClinicalTrials.gov