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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
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.
Quick facts
| Lead sponsor | Stryker Biotech |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 March 2007 |
| Estimated completion | 1 November 2008 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Intra-articular Injection of OP-1 to affected knee — full drug profile →
Conditions studied
- Osteoarthritis of the Knee — all drugs for Osteoarthritis of the Knee →
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.
- Determine safety and tolerability as well as dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of intraarticular OP-1
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):
-
Progress in intra-articular therapy.
Evans CH, Kraus VB, Setton LA. · · 2014 · cited 425× · PMID 24189839 · DOI 10.1038/nrrheum.2013.159 -
Recent advances in the treatment of osteoarthritis.
Grässel S, Muschter D. · · 2020 · cited 172× · PMID 32419923 · DOI 10.12688/f1000research.22115.1 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT00456157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis of the Knee
Currently open trials in the same condition.
- NCT07302204 — Efficacy of Aerobic Exercise Versus Therapeutic Exercises on Exercise-induced Hypoalgesia in Knee Osteoarthritis · NA · recruiting
- NCT06549686 — A Phase III Study of CLS2901C in Patients With Osteoarthritis of the Knee · Phase 3 · recruiting
- NCT05985785 — Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection · NA · recruiting
- NCT05035810 — A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in · Phase 3 · active not recruiting
- NCT04992624 — Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00456157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stryker Biotech
- Last refreshed: 16 June 2010
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing