Trial Outcomes & Findings for Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke (NCT NCT03004976)
NCT ID: NCT03004976
Last Updated: 2022-12-06
Results Overview
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
baseline to 3 months post infusion
Results posted on
2022-12-06
Participant Flow
Participant milestones
| Measure |
Umbilical Cord Blood
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 total nucleated cell count (TNCC)/kg.
|
Placebo
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB (umbilical cord blood) unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
27
|
|
Overall Study
COMPLETED
|
39
|
21
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
Umbilical Cord Blood
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 total nucleated cell count (TNCC)/kg.
|
Placebo
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB (umbilical cord blood) unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
4
|
1
|
Baseline Characteristics
Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Umbilical Cord Blood
n=52 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 months post infusionPopulation: Modified Intention To Treat population (participants who have a baseline and 90 day mRS score)
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Outcome measures
| Measure |
Umbilical Cord Blood
n=47 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=26 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Shift in Modified Rankin Scale (mRS)
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: up to 1 year post infusionPopulation: Safety population
Outcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Infusion Reactions
|
13 reactions
|
4 reactions
|
SECONDARY outcome
Timeframe: up to 1 year post infusionPopulation: Safety population
Outcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Product-related Infections
|
0 infections
|
0 infections
|
SECONDARY outcome
Timeframe: up to 1 year post infusionOutcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Alloimmunization Events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: up to 1 year post infusionPopulation: Safety population
Outcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Graft vs. Host Disease Events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: up to 1 year post infusionPopulation: Safety population
Outcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Study Related and Unexpected Adverse Events (AEs)
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: up to 1 year post infusionPopulation: Safety population
Outcome measures
| Measure |
Umbilical Cord Blood
n=50 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Mortality
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention To Treat population.
Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.
Outcome measures
| Measure |
Umbilical Cord Blood
n=47 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=26 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Number of Participants With Functional Independence
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: baseline to 30 days post infusionPopulation: Modified Intention To Treat population with a 30 day mRS score available
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Outcome measures
| Measure |
Umbilical Cord Blood
n=46 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=25 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion
|
1 shift in score
Interval 0.0 to 1.0
|
1 shift in score
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: baseline to 180 days post infusionPopulation: Modified Intention To Treat population with a 180 day mRS score available
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Outcome measures
| Measure |
Umbilical Cord Blood
n=42 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=24 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion
|
1 shift in score
Interval 1.0 to 2.0
|
1 shift in score
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention To Treat population with NIHSS score available
The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.
Outcome measures
| Measure |
Umbilical Cord Blood
n=41 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=24 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days
|
6 score on a scale
Interval 3.0 to 9.0
|
6 score on a scale
Interval 3.0 to 10.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention To Treat population with BI available at 90 days
The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.
Outcome measures
| Measure |
Umbilical Cord Blood
n=43 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=24 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Barthel Index (BI) Score at 90 Days
|
80 score on a scale
Interval 50.0 to 100.0
|
85 score on a scale
Interval 45.0 to 97.5
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention to Treat population with SIS-16 score available at 90 days
The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.
Outcome measures
| Measure |
Umbilical Cord Blood
n=43 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=24 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Stroke Impact Scale-16 (SIS-16) Score at 90 Days
|
59 score on a scale
Interval 42.0 to 76.0
|
64 score on a scale
Interval 41.5 to 76.5
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention To Treat population with EQ-5D-3L VAS score available at 90 days
The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.
Outcome measures
| Measure |
Umbilical Cord Blood
n=41 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=22 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days
|
70 score on a scale
Interval 50.0 to 85.0
|
75 score on a scale
Interval 55.0 to 80.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intention To Treat population with PHQ 8 score available at 90 days
The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.
Outcome measures
| Measure |
Umbilical Cord Blood
n=39 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=21 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days
|
4 score on a scale
Interval 2.0 to 8.0
|
5 score on a scale
Interval 2.0 to 10.0
|
SECONDARY outcome
Timeframe: 30 days post infusionPopulation: Modified Intent To Treat population with a TICS score at 30 days
The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
Outcome measures
| Measure |
Umbilical Cord Blood
n=34 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=18 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion
|
27 score on a scale
Interval 19.0 to 32.0
|
21 score on a scale
Interval 10.0 to 28.0
|
SECONDARY outcome
Timeframe: 1 year post infusionPopulation: Modified Intent To Treat population with a TICS score at 1 year
The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
Outcome measures
| Measure |
Umbilical Cord Blood
n=31 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=14 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion
|
31 score on a scale
Interval 25.0 to 35.0
|
30 score on a scale
Interval 23.0 to 33.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with Trail A speed available
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.
Outcome measures
| Measure |
Umbilical Cord Blood
n=34 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=15 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Trail Making Test Score at 90 Days Post Infusion (Trail A)
|
78 seconds
Interval 56.0 to 178.0
|
62 seconds
Interval 44.0 to 90.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with Trail B speed available
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.
Outcome measures
| Measure |
Umbilical Cord Blood
n=33 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=15 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Trail Making Test Score at 90 Days Post Infusion (Trail B)
|
278 seconds
Interval 226.0 to 300.0
|
300 seconds
Interval 142.0 to 300.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with MoCA score available at 90 days
The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.
Outcome measures
| Measure |
Umbilical Cord Blood
n=32 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=16 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion
|
21 score on a scale
Interval 14.5 to 24.5
|
20 score on a scale
Interval 8.5 to 24.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with HVLT-R scores available at 90 days
The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.
Outcome measures
| Measure |
Umbilical Cord Blood
n=33 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=16 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion
|
15 score on a scale
Interval 9.0 to 21.0
|
12 score on a scale
Interval 8.5 to 16.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with SF-36 scores available at 90 days
For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.
Outcome measures
| Measure |
Umbilical Cord Blood
n=37 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=18 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Physical Functioning
|
30 score on a scale
Interval 5.0 to 70.0
|
60 score on a scale
Interval 5.0 to 75.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Role Limitations Due to Physical Health
|
0 score on a scale
Interval 0.0 to 25.0
|
0 score on a scale
Interval 0.0 to 25.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Role Limitations Due to Emotional Problems
|
66.7 score on a scale
Interval 0.0 to 100.0
|
100 score on a scale
Interval 0.0 to 100.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Energy/Fatigue
|
55 score on a scale
Interval 45.0 to 70.0
|
65 score on a scale
Interval 45.0 to 85.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Emotional Well-being
|
72 score on a scale
Interval 56.0 to 88.0
|
76 score on a scale
Interval 64.0 to 84.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Social Functioning
|
62.5 score on a scale
Interval 37.5 to 87.5
|
62.5 score on a scale
Interval 50.0 to 87.5
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Pain
|
67.5 score on a scale
Interval 55.0 to 100.0
|
65 score on a scale
Interval 42.5 to 80.0
|
|
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
General Health
|
60 score on a scale
Interval 50.0 to 75.0
|
70 score on a scale
Interval 50.0 to 85.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with COWAT score available at 90 days
The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.
Outcome measures
| Measure |
Umbilical Cord Blood
n=33 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=16 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion
|
14 words
Interval 8.0 to 32.0
|
9.5 words
Interval 6.0 to 22.0
|
SECONDARY outcome
Timeframe: 90 days post infusionPopulation: Modified Intent To Treat population with SDMT score available at 90 days
The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.
Outcome measures
| Measure |
Umbilical Cord Blood
n=30 Participants
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=15 Participants
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion
|
13 associations
Interval 3.0 to 23.0
|
21 associations
Interval 8.0 to 34.0
|
Adverse Events
Umbilical Cord Blood
Serious events: 14 serious events
Other events: 36 other events
Deaths: 4 deaths
Placebo
Serious events: 11 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Umbilical Cord Blood
n=52 participants at risk
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 participants at risk
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Cardiac disorders
HEART FAILURE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Cardiac disorders
CARDIAC ARREST
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Psychiatric disorders
CONFUSION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
General disorders
DEATH NOS
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Infections and infestations
ENDOCARDITIS INFECTIVE
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Injury, poisoning and procedural complications
FALL
|
3.8%
2/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Injury, poisoning and procedural complications
FRACTURE
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
HEADACHE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Vascular disorders
HYPERTENSION
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Vascular disorders
HYPOTENSION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
ISCHEMIA CEREBROVASCULAR
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
SEIZURE
|
3.8%
2/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Infections and infestations
SEPSIS
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Infections and infestations
SKIN INFECTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
STROKE
|
1.9%
1/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
MUSCLE WEAKNESS RIGHT-SIDED
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
Other adverse events
| Measure |
Umbilical Cord Blood
n=52 participants at risk
A single intravenous infusion of umbilical cord blood within 3-10 days following stroke.
Umbilical Cord Blood: Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10\^7 TNCC/kg.
|
Placebo
n=27 participants at risk
A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke.
Placebo: The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 \[pink\]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Blood and lymphatic system disorders
ANEMIA
|
5.8%
3/52 • Up to 1 year
|
14.8%
4/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
ANOREXIA
|
3.8%
2/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
Psychiatric disorders
ANXIETY
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
APNEA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Infections and infestations
BACTEREMIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Investigations
CARDIAC TROPONIN T INCREASED
|
0.00%
0/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
9.6%
5/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Congenital, familial and genetic disorders
CONGENITAL, FAMILIAL AND GENETIC DISORDERS - OTHER
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.9%
1/52 • Up to 1 year
|
14.8%
4/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.9%
1/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
Psychiatric disorders
DELAYED ORGASM
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Psychiatric disorders
DEPRESSION
|
9.6%
5/52 • Up to 1 year
|
18.5%
5/27 • Up to 1 year
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
DIARRHEA
|
7.7%
4/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
DYSPHAGIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Renal and urinary disorders
DYSURIA
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
General disorders
EDEMA LIMBS
|
11.5%
6/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Endocrine disorders
ENDOCRINE DISORDERS - OTHER, SPECIFY
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Eye disorders
EYE PAIN
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Injury, poisoning and procedural complications
FALL
|
11.5%
6/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
General disorders
FATIGUE
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
General disorders
FEVER
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Gastrointestinal disorders
FLATULENCE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
GASTRITIS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
HEADACHE
|
9.6%
5/52 • Up to 1 year
|
14.8%
4/27 • Up to 1 year
|
|
Cardiac disorders
HEART FAILURE
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
Infections and infestations
HEPATITIS B REACTIVATION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.8%
3/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Vascular disorders
HYPERTENSION
|
11.5%
6/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
5.8%
3/52 • Up to 1 year
|
18.5%
5/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Vascular disorders
HYPOTENSION
|
9.6%
5/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Gastrointestinal disorders
ILEUS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Psychiatric disorders
INSOMNIA
|
7.7%
4/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
ISCHEMIA CEREBROVASCULAR
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
13.5%
7/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Infections and infestations
LUNG INFECTION
|
7.7%
4/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIF
|
7.7%
4/52 • Up to 1 year
|
11.1%
3/27 • Up to 1 year
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
7.7%
4/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
23.1%
12/52 • Up to 1 year
|
14.8%
4/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
1.9%
1/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
5.8%
3/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Psychiatric disorders
PERSONALITY CHANGE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Investigations
PLATELET COUNT DECREASED
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Reproductive system and breast disorders
PROSTATIC OBSTRUCTION
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
3.8%
2/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Reproductive system and breast disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER,
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS -
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
SEIZURE
|
5.8%
3/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SP
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Nervous system disorders
SPASTICITY
|
9.6%
5/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
1.9%
1/52 • Up to 1 year
|
14.8%
4/27 • Up to 1 year
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.9%
1/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.6%
5/52 • Up to 1 year
|
18.5%
5/27 • Up to 1 year
|
|
Investigations
URINE OUTPUT DECREASED
|
0.00%
0/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
|
Infections and infestations
VAGINAL INFECTION
|
3.8%
2/52 • Up to 1 year
|
7.4%
2/27 • Up to 1 year
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Gastrointestinal disorders
VOMITING
|
5.8%
3/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER
|
1.9%
1/52 • Up to 1 year
|
0.00%
0/27 • Up to 1 year
|
|
General disorders
PAIN
|
3.8%
2/52 • Up to 1 year
|
3.7%
1/27 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place