StrokePhase 2REGENESISNCT00663416
REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients
A Phase 2 study testing NTx™-265: rhCG, then rEPO in people with Stroke, run by Stem Cell Therapeutics Corp. at 26 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- NTx™-265: rhCG, then rEPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85.
- NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
- Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
- Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
- Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
- Reasonable expectation that patient will receive standard post-stroke physical, occupational and speech therapy as indicated.
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- Female patient is either:
- Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral oophorectomy or hysterectomy) or
- If of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device, contraceptives (e.g., implants, injectables, combined oral, etc) OR
- A vasectomised partner OR
- Abstinence
Who cannot join
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke.
- Patients who have received thrombolytic treatment with tPA following the index stroke.
- Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2)
- Women who have tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
- Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3.
- Advanced liver,kidney, cardiac or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher)
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- Serum bilirubin > 1.5 x upper limit of normal (ULN).
- Alkaline phosphatase > 2.5 x ULN.
- AST>2.5xULN.
- ALT > 2.5 x ULN.
- Creatinine > 2.0 x ULN.
- Patients with known and documented transferrin saturation < 20%.
- Patients with known and documented ferritin < 100 ng/mL.
- Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
- Patients with a known or current history of abnormal hypercoagulability parameters , including known cardiolipin/antiphospholipid antibody syndrome.
- Expected survival < 1 year.
- Allergy or other contraindication to hCG including:
- Prior hypersensitivity to hCG preparations or one of their excipients.
- Primary ovarian failure.
- Uncontrolled thyroid or adrenal dysfunction.
- An uncontrolled organic intracranial lesion such as a pituitary tumor.
- Abnormal uterine bleeding of undetermined origin.
- Ovarian cyst or ovarian enlargement of undetermined origin.
- Sex hormone dependent tumors of the reproductive organs, accessory sex glands, and breasts.
- Allergy or other contraindication to epoetin alfa:
- Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
- With uncontrolled hypertension
- With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
- Who for any reason cannot receive adequate antithrombotic treatment
- A known diagnosis of cancer (except non-malignant skin cancer).
- Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy.
- Use of either hCG or epoetin alfa within the previous 90 days.
- Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor.
- Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2.
- Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
- Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial.
- With the exception of the qualifying stroke, any other stroke within the previous 6 months.
- Patients who cannot take anti-platelet therapy for the duration of the study.
- Patients who cannot take low molecular weight or unfractionated heparin during hospitalization.
- Pre-existing and active major psychiatric or other chronic neurological disease.
- Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependency within 12 months prior to the study.
- Currently participating in another investigational study.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
Canada16 sites
Brandon Regional Health Centre
Brandon, Manitoba, R7A 2B3
Department of Clinical Neurosciences, Univeristy of Calgary
Calgary, Alberta, T2N 2T9
Walter Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
McMaster Clinic
Hamilton, Ontario, L8L 2X2
Chinook Regional Hospital
Lethbridge, Alberta, T1J 1W5
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Division of Neurology , Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Department of Neurology, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network
Toronto, Ontario, M5T 2S8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Vancouver Island Health Research Centre
Victoria, British Columbia, V8R 1J8
India10 sites
M S Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Department of Neurology, Care Hospital
Hyderabad, Andhra Pradesh, 500001
Krishna Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500003
Department of Neurology, Apollo Hospitals
Hyderabad, Andhra Pradesh, 500033
Department of Neurology, Nizam's Institute of Medical Science
Hyderabad, Andhra Pradesh, 500082
AMRI Hospital
Kolkata, West Bengal, 700029
Department of Neurology, B.P.Poddar Hospital & Medical Research Ltd
Kolkata, West Bengal, 700053
Christian Medical College & Hospital
Ludhiana, Punjab, 141008
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110017
Department of Neurology, Christian Medical College
Vellore, Tamil Nadu, 632004
About this study
Official title: 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)
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.
- Conditions
- Stroke
- Being tested
- NTx™-265: rhCG, then rEPO, Saline placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTx™-265: rhCG, then rEPODrug
Also called Ovidrel, Eprex
- rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then
- rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation
Saline placeboDrug
Also called Sodium Chloride 0.9%
- Saline SC, on Day 1, 3, and 5 of study participation, then
- Saline IV, on Day 7, 8, and 9 of study participation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: NTx™-265: rhCG, then rEPO |
| 2 | Placebo comparator | Not described Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Score (mRS)
Measured: Day 90
NIHSS response
Measured: Day 90
Secondary outcomes (8)
NIHSS
Measured: Day 90
mRS
Measured: Day 90
Barthel Index
Measured: Day 90
Action Research Arm Test
Measured: Day 90
Gait Velocity Test
Measured: Day 90
Boston Naming Test
Measured: Day 90
Line Cancellation Test
Measured: Day 90
Trails A & B Test
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cell Therapeutics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael D Hill, MD, Principal investigator, Department of Clinical Neurosciences, University of CalgarySteven C Cramer, MD, Principal investigator, Department of Neurology, University of Califonia, Irvine Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663416
- Sponsor's protocol ID
- NTx™-265-CP-201-IS (CA)
- Acronym
- REGENESIS
- Status last verified
- Aug 2009
- First submitted
- 18 Apr 2008
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00663416
- Acronym / sponsor ID
- REGENESIS / NTx™-265-CP-201-IS (CA)
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Stem Cell Therapeutics Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NTx™-265: rhCG, then rEPO |
| 2 | Placebo comparator | Drug: Saline placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-85.
- NIHSS score 6-24 within 24-48 hours after stroke onset and enrolment.
- Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
- Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
- Reasonable expectation of availability to receive the full 9 day NTxTM-265 course of therapy, and to be available for subsequent follow-up visits.
Key exclusion criteria (42 listed)
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke.
- Patients who have received thrombolytic treatment with tPA following the index stroke.
- Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2)
- Women who have tested positive for pregnancy, or are breast-feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study.
- Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTx™-265: rhCG, then rEPOAlso: Ovidrel, Eprex* rhCG 10,000 IU, SC, on Day 1, 3, and 5 of study participation, then * rEPO 30,000 IU, IV, on Day 7, 8, and 9 of study participation | Drug | 1 |
| Saline placeboAlso: Sodium Chloride 0.9%* Saline SC, on Day 1, 3, and 5 of study participation, then * Saline IV, on Day 7, 8, and 9 of study participation | Drug | 2 |
Primary outcome
Modified Rankin Score (mRS)
Time frame: Day 90
NIHSS response
Time frame: Day 90
8 secondary outcomes
NIHSS
Time frame: Day 90
mRS
Time frame: Day 90
Barthel Index
Time frame: Day 90
Action Research Arm Test
Time frame: Day 90
Gait Velocity Test
Time frame: Day 90
Boston Naming Test
Time frame: Day 90
Line Cancellation Test
Time frame: Day 90
Trails A & B Test
Time frame: Day 90
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Hill, MD principal investigator
Department of Clinical Neurosciences, University of Calgary
Steven C Cramer, MD principal investigator
Department of Neurology, University of Califonia, Irvine Medical Center
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTx™-265: rhCG, then rEPO in people with Stroke, run by Stem Cell Therapeutics Corp. at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Canada, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Score (mRS) (time frame: Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2009.