Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
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ClinicalTrials.gov Identifier: NCT00938314 |
Recruitment Status :
Terminated
(Slow Enrollment)
First Posted : July 13, 2009
Results First Posted : November 9, 2011
Last Update Posted : November 29, 2011
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Sponsor:
Stem Cell Therapeutics Corp.
Information provided by (Responsible Party):
Stem Cell Therapeutics Corp.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Stroke |
Interventions |
Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) Drug: Saline Placebo |
Enrollment | 96 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Baseline Characteristics
Outcome Measures
Adverse Events
Limitations and Caveats
The trial was terminated after 96 of a planned 128 patients were enrolled, thus limiting opportunities to demonstrate a clear statistical benefit of active therapy compared to placebo.
More Information
Results Point of Contact
Name/Title: | Chief Scientific Officer |
Organization: | Stem Cell Therapeutics Corp. |
Phone: | 403.245.5495 ext 226 |
EMail: | adavidoff@stemcellthera.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stem Cell Therapeutics Corp. |
ClinicalTrials.gov Identifier: | NCT00938314 History of Changes |
Other Study ID Numbers: |
NTx®-265-CP-202-IS |
First Submitted: | July 9, 2009 |
First Posted: | July 13, 2009 |
Results First Submitted: | September 1, 2011 |
Results First Posted: | November 9, 2011 |
Last Update Posted: | November 29, 2011 |