Trial Outcomes & Findings for Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI (NCT NCT02481440)

NCT ID: NCT02481440

Last Updated: 2020-06-30

Results Overview

American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 102 participants
• Primary outcome timeframe: at 12 months following the final administration of hUC-MSCs
• Results posted on: 2020-06-30

Participant Flow

Participant milestones

Measure	hUC-MSC Transplantation Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Overall Study STARTED	102
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Age, Continuous	38.1 years STANDARD_DEVIATION 11.0 • n=41 Participants
Sex: Female, Male Female	8 Participants n=41 Participants
Sex: Female, Male Male	33 Participants n=41 Participants
Region of Enrollment China	41 participants n=41 Participants
Chronicity of SCI	45.15 months STANDARD_DEVIATION 59.78 • n=41 Participants

PRIMARY outcome

Timeframe: at 12 months following the final administration of hUC-MSCs

American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up	183.88 score Standard Deviation 69.76

PRIMARY outcome

Timeframe: at 12 months following the final administration of hUC-MSCs

SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) form is used to assess IANR-SCIFRS total score (Range: 0-51 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up	29.49 score Standard Deviation 10.47

SECONDARY outcome

Timeframe: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs

American Spinal Injury Association (ASIA) form is used to assess ASIA total score (Range: 0-324 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
American Spinal Injury Association (ASIA) Total Score 1st transplantation	158.15 score Standard Deviation 70.93
American Spinal Injury Association (ASIA) Total Score 3rd follow-up	182.44 score Standard Deviation 71.00
American Spinal Injury Association (ASIA) Total Score 2nd follow-up	178.39 score Standard Deviation 71.51
American Spinal Injury Association (ASIA) Total Score 1st follow-up	176.05 score Standard Deviation 71.88
American Spinal Injury Association (ASIA) Total Score 4th transplantation	172.00 score Standard Deviation 73.51
American Spinal Injury Association (ASIA) Total Score 3rd transplantation	168.41 score Standard Deviation 74.16
American Spinal Injury Association (ASIA) Total Score 2nd transplantation	163.80 score Standard Deviation 72.53

SECONDARY outcome

Timeframe: at first, second, third, and fourth transplantation and 1, 3, 6 months following the final administration of hUC-MSCs

SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) form is used to assess IANR-SCIFRS total score (Range: 0-51 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 3rd follow-up	28.93 score Standard Deviation 10.26
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 2nd follow-up	28.44 score Standard Deviation 10.28
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 1st follow-up	27.56 score Standard Deviation 10.03
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 4th transplantation	26.85 score Standard Deviation 10.36
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 3rd transplantation	26.05 score Standard Deviation 10.15
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 2nd transplantation	25.71 score Standard Deviation 10.32
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score 1st transplantation	24.54 score Standard Deviation 9.82

SECONDARY outcome

Timeframe: at first transplantation and 12 months following the final administration of hUC-MSCs

International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) form is used to assess ISAFSCI score (autonomic nervous function) (Range: 5-32 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score 4th follow-up	12 score Interval 11.0 to 14.0
International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score 1st transplantation	11 score Interval 10.0 to 12.0

SECONDARY outcome

Timeframe: at first transplantation and 12 months following the final administration of hUC-MSCs

Penn scale form is used to assess muscle spasm (Range: 0-4 scores). The higher scores mean a worse outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Penn Scale 4th follow-up	1 score Interval 0.0 to 2.0
Penn Scale 1st transplantation	1 score Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: at first transplantation and 1, 3, 12 months following the final administration of hUC-MSCs

Modified Ashworth scale form is used to assess muscle spasticity (Range: 0-16 scores). The higher scores mean a worse outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Modified Ashworth Scale 4th follow-up	2 score Interval 0.0 to 4.0
Modified Ashworth Scale 2nd follow-up	2 score Interval 0.0 to 4.0
Modified Ashworth Scale 1st follow-up	2.5 score Interval 0.0 to 4.5
Modified Ashworth Scale 1st transplantation	3 score Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: at first transplantation and 12 months following the final administration of hUC-MSCs

Geffner scale form is used to assess bladder function (Range: 0-7 scores). The higher scores mean a better outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Geffner Scale 4th follow-up	3 score Interval 2.0 to 4.0
Geffner Scale 1st transplantation	2 score Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: at first transplantation and 12 months following the final administration of hUC-MSCs

Neurogenic Bowel Dysfunction (NBD) scale form is used to assess bowel function (Range: 0-47 scores). The higher scores mean a worse outcome.

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Neurogenic Bowel Dysfunction (NBD) Scale 4th follow-up	3 score Interval 2.0 to 10.0
Neurogenic Bowel Dysfunction (NBD) Scale 1st transplantation	6 score Interval 2.0 to 12.5

SECONDARY outcome

Timeframe: at first transplantation and 12 months following the final administration of hUC-MSCs

Ultrasonic examination is used to assess residual urine volume

Outcome measures

Measure	hUC-MSC Transplantation n=41 Participants Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Residual Urine Volume 4th follow-up	27.90 ml Interval 8.83 to 88.5
Residual Urine Volume 1st transplantation	67.65 ml Interval 31.58 to 144.5

Adverse Events

hUC-MSC Transplantation

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	hUC-MSC Transplantation n=102 participants at risk Four times of intrathecal administrations of 1x10E6 human umbilical cord mesenchymal stem cells per kg in subjects with spinal cord injury with an interval of one month between each administration
Nervous system disorders transient increase of muscle tension	2.0% 2/102 • Number of events 6 • During the intervention and follow-up periods of this trial, up to 16 months, any AE was identified and collected.
Immune system disorders fever	24.5% 25/102 • Number of events 54 • During the intervention and follow-up periods of this trial, up to 16 months, any AE was identified and collected.
Nervous system disorders headache	13.7% 14/102 • Number of events 16 • During the intervention and follow-up periods of this trial, up to 16 months, any AE was identified and collected.
Nervous system disorders dizziness	2.9% 3/102 • Number of events 5 • During the intervention and follow-up periods of this trial, up to 16 months, any AE was identified and collected.

Additional Information

Li-Min Rong M.D., Director of Clinical Trials

The Third Affiliated Hospital of Sun Yat-sen University

Phone: 862085252900

Email: ronglimin@21cn.com, ronglm@mail.sysu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place