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NCT00456157: Knee OA

A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular Osteogenic Protein-1 OP-1 in Subjects With Osteoarthritis of the Knee

Completed Phase 1 Last updated 16 June 2010
What this trial tests

Phase 1 trial testing Intra-articular Injection of OP-1 to affected knee in Osteoarthritis of the Knee in 33 participants. Completed in 1 November 2008.

Timeline
1 March 2007
1 November 2008

Quick facts

Lead sponsorStryker Biotech
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingdouble
Primary purposetreatment
Enrollment33
Start date1 March 2007
Estimated completion1 November 2008
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stryker Biotech — full company profile →

Who can join

40 and older, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Progress in intra-articular therapy.
    Evans CH, Kraus VB, Setton LA. · · 2014 · cited 425× · PMID 24189839 · DOI 10.1038/nrrheum.2013.159
  2. Recent advances in the treatment of osteoarthritis.
    Grässel S, Muschter D. · · 2020 · cited 172× · PMID 32419923 · DOI 10.12688/f1000research.22115.1
  3. Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis.
    Hunter DJ, Pike MC, Jonas BL, Kissin E, et al · · 2010 · cited 103× · PMID 20932341 · DOI 10.1186/1471-2474-11-232
  4. Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.
    Hao ZW, Zhang ZY, Wang ZP, Wang Y, et al · · 2024 · cited 24× · PMID 39639374 · DOI 10.1186/s40779-024-00576-x
  5. The Current Status of Clinical Trials on Biologics for Cartilage Repair and Osteoarthritis Treatment: An Analysis of ClinicalTrials.gov Data.
    Zhang Z, Schon L. · · 2022 · cited 21× · PMID 35546280 · DOI 10.1177/19476035221093065
  6. Recent Advances in Small Molecule Inhibitors for the Treatment of Osteoarthritis.
    Lin J, Jia S, Zhang W, Nian M, et al · · 2023 · cited 18× · PMID 36902773 · DOI 10.3390/jcm12051986
  7. Small molecule inhibitors of osteoarthritis: Current development and future perspective.
    Liu D, Li X, Zhang L, Hu B, et al · · 2023 · cited 10× · PMID 37089415 · DOI 10.3389/fphys.2023.1156913
  8. Unraveling Osteoarthritis: Mechanistic Insights and Emerging Therapies Targeting Pain and Inflammation.
    Alad M, Yousef F, Epure LM, Lui A, et al · · 2025 · cited 6× · PMID 40563514 · DOI 10.3390/biom15060874

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Other recruiting trials for Osteoarthritis of the Knee

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00456157.

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