StrokePhase 2REGENESISNCT00715364
REGENESIS (US): 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
A Phase 2 study testing NTx™-265: rhCG, then rEPO in people with Stroke, run by Stem Cell Therapeutics Corp. at 2 sites in United States.
Trial summary
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. 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
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Sep 2010
- 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 NTx™-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 NTx™-265 course of therapy, and to be available for subsequent follow-up visits.
- Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive 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 tubal ligation, 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: i) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (e.g. implants, injectables, combined oral, etc.) OR ii) a vasectomized partner OR iii) abstinence
Who cannot join
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- Patients classified as comatose, defined as a patient who requires 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)
- Serum bilirubin > 1.5 x ULN
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- Alkaline phosphatase > 2.5 x ULN
- AST or ALT > 2.5 x ULN
- Creatinine > 2.0 x ULN
- Patients with known and documented Transferrin saturation <20% or ferritin < 100 ng/ml
- Patients with known and documented elevated PSA levels
- Patients with a known history of hypercoagulability, including known cardiolipin/antiphospholipid antibody syndrome
- Expected survival < 1 year
- Allergy or other contraindication to hCG
- Allergy or other contraindication to epoetin alfa:
- 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 3 months
- Patients who cannot take anti-platelet or anti-coagulant therapy
- 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
2 sites in 1 country.
United States2 sites
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
University of California, Irvine Medical Center
Orange, California, 92868-4280
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
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.
- 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, Epogen
- rhCG 385 µg, 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.
Adverse events
Measured: screening to Day 90
Secondary outcomes (8)
mRS
Measured: Day 90
NIHSS
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 posted15 Jul 2008 (estimated)
- Study startAug 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cell Therapeutics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven C Cramer, MD, MMSc, Principal investigator, Department of Neurology, University of Califonia, Irvine Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715364
- Sponsor's protocol ID
- NTx™-265-CP-201-IS (US)
- Acronym
- REGENESIS
- Status last verified
- Sep 2011
- First submitted
- 9 Jul 2008
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. 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
- ClinicalTrials.gov ID
- NCT00715364
- Acronym / sponsor ID
- REGENESIS / NTx™-265-CP-201-IS (US)
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stem Cell Therapeutics Corp.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 15 Jul 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.
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.
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 (9 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 NTx™-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 NTx™-265 course of therapy, and to be available for subsequent follow-up visits.
Key exclusion criteria (27 listed)
- Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
- Patients classified as comatose, defined as a patient who requires 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)
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, Epogen* rhCG 385 µg, 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
Adverse events
Time frame: screening to Day 90
8 secondary outcomes
mRS
Time frame: Day 90
NIHSS
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 withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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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.
Steven C Cramer, MD, MMSc principal investigator
Department of Neurology, University of Califonia, Irvine Medical Center
2 sites in 1 country: 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 2 sites in United States.
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 9 inclusion and 27 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: withdrawn, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Adverse events (time frame: screening to Day 90). 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 5 Sep 2011.