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NCT03479749

The Effect of Intra-Articular Injection of RegenoGel-OSP™ (Self-Plasma) and RegenoGel™ on Knee Pain in People Suffering From Osteoarthritis

Completed NA Last updated 24 September 2021
What this trial tests

NA trial testing RegenoGel-OSP, RegenoGel in Osteoarthritis, Knee in 67 participants. Completed in 4 March 2019.

Timeline
7 February 2018
Primary endpoint
4 March 2019
4 March 2019

Quick facts

Lead sponsorProCore Ltd.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment67
Start date7 February 2018
Primary completion4 March 2019
Estimated completion4 March 2019
Sites5 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

ProCore Ltd.

Who can join

Adults 55 to 80, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ and RegenoGel™ to treat knee pain and effect on subject's activity and quality of life. During the study the subjects will receive two treatments at a 3-month interval. The study is double-blinded. The subjects will be randomized and sequentially assigned to RegenoGel-OSP™, RegenoGel or placebo treatment in the first treatment. In the second treatment after interval of three months all the subjects will necessarily receive one of the two active products. The follow-up period will continue for one year after first treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A novel approach for knee osteoarthritis using high molecular weight hyaluronic acid conjugated to plasma fibrinogen - interim findings of a double-blind clinical study.
    Kandel L, Agar G, Elkayam O, Sharipov A, et al · · 2020 · cited 9× · PMID 32743094 · DOI 10.1016/j.heliyon.2020.e04475

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Data sources for this page

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