Study Stopped
Slow Enrollment
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
REGENESIS-LED
A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled, Multicenter, Dose Escalation Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)
1 other identifier
interventional
96
3 countries
23
Brief Summary
The purpose of this study is:
- To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
- To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 stroke
Started Aug 2009
Shorter than P25 for phase_2 stroke
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
November 9, 2011
CompletedNovember 29, 2011
November 1, 2011
8 months
July 9, 2009
September 1, 2011
November 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90
The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).
Baseline and Day 90
Secondary Outcomes (11)
NIHSS Response >=4 at Day 90
Baseline and Day 90
NIHSS Change From Baseline at Day 30
Baseline and Day 30
Modified Rankin Scale (mRS) Response <=2 at Day 90
Day 90
Barthel Index at Day 90
Day 90
Action Research Arm Test (ARAT) Change From Baseline at Day 90
Baseline and Day 90
- +6 more secondary outcomes
Study Arms (4)
NTx®-265 Low Dose
EXPERIMENTALhCG 385 µg (10,000 international unit \[IU\]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
NTx®-265 Medium Dose
EXPERIMENTALhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
NTx®-265 High Dose
EXPERIMENTALhCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
Saline Placebo
PLACEBO COMPARATORInterventions
hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
Saline SC, on Day 1, 3, and 5 of study participation, then Saline IV, on Day 7, 8, and 9 of study participation
Eligibility Criteria
You may qualify if:
- Age 18-85
- NIHSS score 8-20
- Stroke is ischemic in origin, supratentorial, and radiologically confirmed
- Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
- Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
- Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
- Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study
You may not qualify if:
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- Patients who have received tissue plasminogen activator (tPA)following the index stroke
- Patients classified as comatose
- Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
- Serum hemoglobin \> 16 grams(g)/deciliter (dL)(males) or \> 14 g/dL (females); or platelet count \> 400,000/cubic millimeters(mm3)
- Advanced liver, kidney, cardiac, or pulmonary disease
- Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
- Patients with a known history of hypercoagulability
- Expected survival \< 1 year
- Allergy or other contraindication to hCG or EPO
- A known diagnosis of cancer in the previous 5 years
- Uncontrolled hypertension
- Use of either hCG or epoetin alfa within the previous 90 days
- Any condition known to elevate hCG
- Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of California, Irvine Medical Center
Orange, California, 92868, United States
Foothills Medical Center , University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4, Canada
Lalitha Super Specialty Hospitals Pvt.Ltd
Guntur, Andhra Pradesh, 522001, India
Care Hospital
Hyderabad, Andhra Pradesh, 500001, India
Krishna Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500003, India
St.Theresa's General Hospital
Hyderabad, Andhra Pradesh, 500018, India
Apollo Hospitals
Hyderabad, Andhra Pradesh, 500023, India
Owaisi Hospital and Research Centre
Hyderabad, Andhra Pradesh, 500059, India
Mediciti Hospital
Hyderabad, Andhra Pradesh, 500063, India
Kamineni Hospital
Hyderabad, Andhra Pradesh, 500068, India
DBR & SK Super Speciality Hospital
Tirupati, Andhra Pradesh, 517501, India
Latha Superspecialities Hospital
Vijayawada, Andhra Pradesh, 520002, India
Suraksha Neuro Centre
Vijayawada, Andhra Pradesh, 520002, India
M S Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054, India
J.S.S Medical College & Hospital
Bangalore, Karnataka, 570004, India
Ananthapuri Hospitals and Research Institute
Thiruvananthapuram, Kerala, 695024, India
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110017, India
Christian Medical College and Hospital
Ludhiana, Punjab, 141008, India
Vijaya Health Center
Chennai, Tamil Nadu, 600026, India
Christian Medical College Hospital
Vellore, Tamil Nadu, 632004, India
Related Publications (1)
Cramer SC, Hill MD; REGENESIS-LED Investigators. Human choriogonadotropin and epoetin alfa in acute ischemic stroke patients (REGENESIS-LED trial). Int J Stroke. 2014 Apr;9(3):321-7. doi: 10.1111/ijs.12260. Epub 2014 Mar 3.
PMID: 24588854DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Stem Cell Therapeutics Corp.
Study Officials
- PRINCIPAL INVESTIGATOR
Steven C Cramer, MD
Department of Neurology, University of California, Irvine Medical Center
- PRINCIPAL INVESTIGATOR
Michael D Hill, MD
Department of Clinical Neurosciences, University of Calgary
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 13, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 29, 2011
Results First Posted
November 9, 2011
Record last verified: 2011-11