Trial Outcomes & Findings for Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss (NCT NCT02038972)
NCT ID: NCT02038972
Last Updated: 2026-07-09
Results Overview
To determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is safe.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2026-07-09
Participant Flow
Participant milestones
| Measure |
Autologous Stem Cells
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Autologous Stem Cells
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
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Baseline Characteristics
Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss
Baseline characteristics by cohort
| Measure |
Autologous Stem Cells
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|
|
Age, Continuous
|
30.27 months
STANDARD_DEVIATION 25.3 • n=20 Participants
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|
Sex: Female, Male
Female
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5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
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6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 yearTo determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is safe.
Outcome measures
| Measure |
Autologous Stem Cells
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|---|---|---|
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Safety of Autologous Stem Cell Infusion: Number of Participants With Adverse Events.
|
0 Participants
|
—
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—
|
—
|
PRIMARY outcome
Timeframe: 1 monthTo determine if autologous human umbilical cord blood (hUBC) infusion in children with hearing loss is feasible.
Outcome measures
| Measure |
Autologous Stem Cells
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|---|---|---|
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Feasibility of Autologous Stem Cell Infusion: Number of Participants Who Completed Cord Blood Infusion and 1 Month Follow-up.
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11 Participants
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—
|
—
|
—
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SECONDARY outcome
Timeframe: Pre-treatment (Baseline), 1,6 & 12 months post-treatmentPopulation: After the 1 month follow-up visit, two subjects dropped out.
ABR Threshold is a measure of the sound necessary to activate transmission through the eighth cranial nerve. Each participant was evaluated before, 1,6 and 12 months after autologous stem cell treatments. For each ear, ABR threshold was measured at 500, 1000, 2000 and 4000 Hz and using "Click" ABR.
Outcome measures
| Measure |
Autologous Stem Cells
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
n=9 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
n=9 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|---|---|---|
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Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f1 Left Ear Click
|
59.09 decibels
Standard Deviation 27.00
|
47.27 decibels
Standard Deviation 23.60
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50.91 decibels
Standard Deviation 23.86
|
47.78 decibels
Standard Deviation 23.06
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f2 Right Ear Click
|
58.00 decibels
Standard Deviation 22.39
|
53.64 decibels
Standard Deviation 15.98
|
59.09 decibels
Standard Deviation 23.22
|
48.13 decibels
Standard Deviation 11.00
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f3 Left Ear 500 Hz
|
60.45 decibels
Standard Deviation 23.71
|
60.38 decibels
Standard Deviation 25.66
|
57.00 decibels
Standard Deviation 22.39
|
56.67 decibels
Standard Deviation 25.00
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f4 Right Ear 500 Hs
|
60.00 decibels
Standard Deviation 27.11
|
56.36 decibels
Standard Deviation 25.21
|
56.00 decibels
Standard Deviation 24.81
|
56.67 decibels
Standard Deviation 24.87
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f5 Left Ear 1000 Hz
|
52.78 decibels
Standard Deviation 21.23
|
51.50 decibels
Standard Deviation 23.46
|
49.44 decibels
Standard Deviation 23.51
|
51.88 decibels
Standard Deviation 24.04
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f6 Right Ear 1000 Hz
|
63.75 decibels
Standard Deviation 29.24
|
57.08 decibels
Standard Deviation 25.62
|
61.67 decibels
Standard Deviation 24.89
|
53.13 decibels
Standard Deviation 20.34
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f7 Left Ear 2000 Hz
|
60.50 decibels
Standard Deviation 21.27
|
55.83 decibels
Standard Deviation 27.21
|
65.00 decibels
Standard Deviation 23.09
|
58.13 decibels
Standard Deviation 17.92
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f8 Right Ear 2000 Hz
|
63.64 decibels
Standard Deviation 24.30
|
61.67 decibels
Standard Deviation 24.15
|
62.00 decibels
Standard Deviation 23.24
|
55.63 decibels
Standard Deviation 17.00
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f9 Left Ear 4000 Hz
|
60.00 decibels
Standard Deviation 25.69
|
64.23 decibels
Standard Deviation 27.98
|
58.33 decibels
Standard Deviation 22.22
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58.13 decibels
Standard Deviation 21.70
|
|
Change in Auditory Brainstem Response (ABR) Threshold in Decibels.
f10 Right Ear 4000Hz
|
62.50 decibels
Standard Deviation 25.41
|
60.83 decibels
Standard Deviation 27.70
|
61.11 decibels
Standard Deviation 25.83
|
58.13 decibels
Standard Deviation 25.20
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SECONDARY outcome
Timeframe: Pre-treatment (Baseline), 1,6 & 12 months post-treatmentPopulation: After the 1 month follow-up visit, two subjects dropped out.
.For each ear, latency was measured at 500, 1000, 2000 and 4000 Hz and using "Click" ABR.
Outcome measures
| Measure |
Autologous Stem Cells
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
n=11 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
n=9 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
n=9 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
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|---|---|---|---|---|
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Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f9 Left Ear 4000 Hz
|
6.75 milliseconds
Standard Deviation 1.40
|
6.52 milliseconds
Standard Deviation 1.09
|
6.27 milliseconds
Standard Deviation 1.50
|
6.30 milliseconds
Standard Deviation 1.46
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f10 Right Ear 4000Hz
|
1.73 milliseconds
Standard Deviation 1.31
|
1.13 milliseconds
Standard Deviation 1.64
|
1.84 milliseconds
Standard Deviation 0.94
|
1.99 milliseconds
Standard Deviation 0.91
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f5 Left Ear 1000 Hz
|
3.77 milliseconds
Standard Deviation 2.66
|
3.59 milliseconds
Standard Deviation 2.59
|
1.40 milliseconds
Standard Deviation 3.55
|
2.47 milliseconds
Standard Deviation 1.84
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f6 Right Ear 1000 Hz
|
5.55 milliseconds
Standard Deviation 1.68
|
5.61 milliseconds
Standard Deviation 1.52
|
4.29 milliseconds
Standard Deviation 2.13
|
4.48 milliseconds
Standard Deviation 1.00
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f7 Left Ear 2000 Hz
|
1.36 milliseconds
Standard Deviation 0.19
|
1.65 milliseconds
Standard Deviation 0.45
|
1.47 milliseconds
Standard Deviation 0.22
|
1.46 milliseconds
Standard Deviation 0.51
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f8 Right Ear 2000 Hz
|
3.95 milliseconds
Standard Deviation 0.48
|
4.01 milliseconds
Standard Deviation 0.33
|
3.72 milliseconds
Standard Deviation 0.27
|
3.78 milliseconds
Standard Deviation 0.56
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f1 Left Ear Click
|
1.33 milliseconds
Standard Deviation 0.09
|
1.38 milliseconds
Standard Deviation 0.08
|
1.53 milliseconds
Standard Deviation 0.42
|
1.26 milliseconds
Standard Deviation 0.17
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f2 Right Ear Click
|
3.78 milliseconds
Standard Deviation 0.34
|
3.93 milliseconds
Standard Deviation 0.45
|
3.98 milliseconds
Standard Deviation 0.56
|
3.60 milliseconds
Standard Deviation 0.36
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f3 Left Ear 500 Hz
|
6.51 milliseconds
Standard Deviation 1.26
|
6.40 milliseconds
Standard Deviation 1.07
|
6.05 milliseconds
Standard Deviation 1.23
|
5.55 milliseconds
Standard Deviation 0.65
|
|
Change in Eight Cranial Nerve Wave 5 Latencies in Miliseconds.
f4 Right Ear 500 Hs
|
1.96 milliseconds
Standard Deviation 1.07
|
2.02 milliseconds
Standard Deviation 1.67
|
2.38 milliseconds
Standard Deviation 1.06
|
2.01 milliseconds
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Pre-treatment, 6 & 12 months post-treatmentPreschool Language Scale-5. This test measures language development in infants and children. Standard scores are derived, with a mean of 100 and a standard deviation of 15, to compare a child's performance to their peers. Higher values are associated with better language development.
Outcome measures
| Measure |
Autologous Stem Cells
n=9 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
|---|---|---|---|---|
|
Change in Standard Language Scores.
Month 6-Pre-treatment
|
2.4 units on a scale
Standard Deviation 9.8
|
—
|
—
|
—
|
|
Change in Standard Language Scores.
Month 12-Pre-treatment
|
12.5 units on a scale
Standard Deviation 14.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment & 12 months post-treatmentPopulation: All participants who completed the trial and had appropriate MRI data before and after treatment. There were 4 "responders" and 4 "non-responders" analyzed.
Fractional anisotropy are arbitrary values generated from the DTI sequences of an MRI scan. Higher values suggest increased integrity of white matter pathways. Responders and nonresponders were evaluated separately. (Define non-responders and responders).Although 11 subjects were enrolled and received an autologous cord blood infusion, three subjects did not complete the entire MRI study protocol and could not be analyzed at study completion. The reasons these subjects did not undergo the second MRI are as follows: Subject 7 dropped out of the study, and Subject 11 underwent bilateral cochlear implantation after the 1-month follow-up. Subject 10 refused testing at 12-month follow-up.
Outcome measures
| Measure |
Autologous Stem Cells
n=8 Participants
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cells-1 Month Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-6 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
Autologous Stem Cell-12 Months Post-treatment
A single dose of intravenously administered autologous hUCB will be done. The minimum acceptable dose will be 6x10 6th mononuclear cells/kilogram body weight. The hUCB reanimation, cell processing and product infusion will occur at Florida Hospital for Children and the Florida Hospital Center for Cellular Therapy.
Autologous Stem Cells: The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
|
|---|---|---|---|---|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Nonresponder Baseline Right
|
0.2 unitless
Standard Deviation 0.05
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Nonresponder Baseline Left
|
0.21 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Responder Baseline Right
|
0.22 unitless
Standard Deviation 0.05
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Responder Baseline Left
|
0.19 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Nonresponder 12 Month Right
|
0.26 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Nonresponder 12 Month Left
|
0.18 unitless
Standard Deviation 0.05
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Responder 12 Month Right
|
0.26 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
|
Change Fractional Anisotropy in the White Sites Along the Audiotory Pathways
Responder 12 Month Left
|
0.24 unitless
Standard Deviation 0.06
|
—
|
—
|
—
|
Adverse Events
Autologous Stem Cells
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
James Baumgartner, Surgical Director Comprehensive Epilepsy Program
Florida Hospital
Phone: 4072360006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place