Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients (REGENESIS-LED)

This study has been terminated.

(Slow Enrollment)

Sponsor:

Information provided by (Responsible Party):

Stem Cell Therapeutics Corp.

ClinicalTrials.gov Identifier:

NCT00938314

First received: July 9, 2009

Last updated: November 24, 2011

Last verified: November 2011

History of Changes

Results First Received: September 1, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Stroke
Interventions:	Drug: human chorionic gonadotropin (hCG), then epoetin alfa (EPO) Drug: Saline Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
NTx®-265 Low Dose	human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
NTx®-265 Medium Dose	hCG 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	hCG 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
Placebo	saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation

Participant Flow for 3 periods

Period 1: Cohort 1

	NTx®-265 Low Dose	Placebo
STARTED	24	8
COMPLETED	22	6
NOT COMPLETED	2	2

Period 2: Cohort 2

	NTx®-265 Medium Dose	Placebo
STARTED	24	8
COMPLETED	18	6
NOT COMPLETED	6	2

Period 3: Cohort 3

	NTx®-265 High Dose	Placebo
STARTED	24	8
COMPLETED	20	7
NOT COMPLETED	4	1

Baseline Characteristics

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Reporting Groups

	Description
NTx®-265 Low Dose	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
NTx®-265 Medium Dose	hCG 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	hCG 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	saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
Total	Total of all reporting groups

Baseline Measures

	NTx®-265 Low Dose	NTx®-265 Medium Dose	NTx®-265 High Dose	Saline Placebo	Total
Number of Participants [units: participants]	24	24	24	24	96
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	21	17	17	12	67
>=65 years	3	7	7	12	29
Age [units: years] Mean ± Standard Deviation	57.42 ± 10.49	58.58 ± 13.32	54.83 ± 12.98	61.67 ± 12.38	58.13 ± 12.39
Gender [units: participants]
Female	18	14	17	16	65
Male	6	10	7	8	31
Region of Enrollment [units: participants]
Canada	0	2	0	0	2
India	24	22	24	24	94

Outcome Measures

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1. Primary:

National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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2. Secondary:

NIHSS Response >=4 at Day 90 [ Time Frame: Baseline and Day 90 ]

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3. Secondary:

NIHSS Change From Baseline at Day 30 [ Time Frame: Baseline and Day 30 ]

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4. Secondary:

Modified Rankin Scale (mRS) Response <=2 at Day 90 [ Time Frame: Day 90 ]

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5. Secondary:

Barthel Index at Day 90 [ Time Frame: Day 90 ]

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6. Secondary:

Action Research Arm Test (ARAT) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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7. Secondary:

Gait Velocity Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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8. Secondary:

Boston Naming Test (BNT) Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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9. Secondary:

Line Cancellation Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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10. Secondary:

Trails A Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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11. Secondary:

Trails B Test Change From Baseline at Day 90 [ Time Frame: Baseline and Day 90 ]

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12. Secondary:

Geriatric Depression Scale at Day 90 [ Time Frame: Day 90 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Chief Scientific Officer
Organization: Stem Cell Therapeutics Corp.
phone: 403.245.5495 ext 226
e-mail: adavidoff@stemcellthera.com

No publications provided

Responsible Party:	Stem Cell Therapeutics Corp.
ClinicalTrials.gov Identifier:	NCT00938314 History of Changes
Other Study ID Numbers:	NTx®-265-CP-202-IS
Study First Received:	July 9, 2009
Results First Received:	September 1, 2011
Last Updated:	November 24, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada India: Drugs Controller General of India

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