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NCT00663416: REGENESIS
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS)
Phase 2 trial testing NTx™-265: rhCG, then rEPO in Stroke in 134 participants. Terminated before completion.
1 October 2008
Quick facts
| Lead sponsor | Stem Cell Therapeutics Corp. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 134 |
| Start date | 1 March 2008 |
| Primary completion | 1 October 2008 |
| Estimated completion | 1 January 2009 |
| Sites | 26 locations across Canada, India |
Drugs / interventions tested
- NTx™-265: rhCG, then rEPO — full drug profile →
- Saline placebo
Conditions studied
- Stroke — all drugs for Stroke →
Sponsor
Stem Cell Therapeutics Corp. — full company profile →
Who can join
Adults 18 to 85, any sex, with Stroke. 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.
-
Modified Rankin Score (mRS)
Time frame: Day 90 -
NIHSS response
Time frame: Day 90
Sponsor's own description
Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control. Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Therapeutic potential of erythropoietin and its structural or functional variants in the nervous system.
Sirén AL, Fasshauer T, Bartels C, Ehrenreich H. · · 2009 · cited 162× · PMID 19110203 · DOI 10.1016/j.nurt.2008.10.041 -
Growth factors in ischemic stroke.
Lanfranconi S, Locatelli F, Corti S, Candelise L, et al · · 2011 · cited 69× · PMID 20015202 · DOI 10.1111/j.1582-4934.2009.00987.x
Verify or expand the search:
- PubMed search for NCT00663416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stroke
Currently open trials in the same condition.
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- NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · 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 NCT00663416 (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 Stem Cell Therapeutics Corp.
- Last refreshed: 10 August 2009
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/NCT00663416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing