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NCT00715364: 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
Phase 2 trial testing NTx™-265: rhCG, then rEPO in Stroke in 30 participants. Withdrawn.
1 June 2010
Quick facts
| Lead sponsor | Stem Cell Therapeutics Corp. |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 August 2009 |
| Primary completion | 1 June 2010 |
| Estimated completion | 1 September 2010 |
| Sites | 2 locations across United States |
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.
-
Adverse events
Time frame: screening to Day 90
Sponsor's own description
To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients. To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.
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 NCT00715364
- 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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- NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
- 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 NCT00715364 (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: 2 September 2011
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/NCT00715364.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing