Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI

NCT02481440 | Completed Phase 1 Results DMC

• 1 other identifier: hUC-MSC-SCI
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of repeated intrathecal administrations of allogeneic human umbilical cord mesenchymal stem cells for the treatment of spinal cord injury.

Conditions

Spinal Cord Injuries

Keywords

human umbilical cord mesenchymal stem cells; spinal cord injury

Outcome Measures

Primary Outcomes (2)

• American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up

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

  at 12 months following the final administration of hUC-MSCs

• SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up

  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.

  at 12 months following the final administration of hUC-MSCs

Secondary Outcomes (8)

• American Spinal Injury Association (ASIA) Total Score

  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) Total Score

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

• International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score

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

• Penn Scale

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

• Modified Ashworth Scale

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

Study Arms (1)

hUC-MSC Transplantation

EXPERIMENTAL

Repeated 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

Biological: human umbilical cord mesenchymal stem cells (hUC-MSCs)

Interventions

human umbilical cord mesenchymal stem cells (hUC-MSCs) BIOLOGICAL

Four times of intrathecal administrations of hUC-MSCs

Also known as: umbilical cord mesenchymal stem cells

hUC-MSC Transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• complete or incomplete trauma-induced SCI \[American Spinal Injury Association (ASIA) Impairment Scale classification: A-D\] that happened at least two months before recruitment;
• aged between 18 and 65 years;
• agreed to participate in this study voluntarily and be regularly followed up for 12 months after the completion of hUC-MSCs administration

You may not qualify if:

• ankylosing spondylitis, myelitis, or vascular abnormalities within the spinal cord parenchyma;
• severe comorbidities, including but not limited to craniocerebral injury, cutaneous back infection, psychiatric disease, or cancer;
• pregnancy or lactation (for females);
• predicted lifespan of less than 12 months following the end of hUC-MSCs transplantation;
• participation in any other stem cell-related clinical trials that might affect accurate neurological evaluations in the present trial;
• any medical condition that, in the opinion of investigators, may pose a safety risk to any subject in this study, confound safety or efficacy assessments, or interfere with study participation
• Rejection Criteria:
• misdiagnosis;
• use of any medication that may significantly impact the assessment accuracy of stem cell engraftment;
• absence of any evaluation outcome at any time point during the follow-up period
• Cessation Criteria:
• individual wishes of the subjects;
• occurrence of any stem cell-associated serious adverse event (SAE) that may aggravate neurological dysfunction, or require prolongation of existing hospitalization, or need hospital readmission, or impair consciousness, or be life-threatening, or even lead to death in any subject;
• detection of any major mistake in the present protocol during the implementation of this clinical trial;
• the national administration agency requires the clinical trial to be halted

Sponsors & Collaborators

• Limin Rong: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Li-Min Rong M.D., Director of Clinical Trials
• Organization: The Third Affiliated Hospital of Sun Yat-sen University

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

862085252900

Study Officials

• Min Li Rong, M.D.

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Spine Surgery Department

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 25, 2015
• Study Start: March 30, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 30, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)