Phase 2
N=102
Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02481440 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up — 183.88 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- human umbilical cord mesenchymal stem cells (hUC-MSCs) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Limin Rong
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up |
183.88 | — |
| PRIMARY SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up |
29.49 | — |
| SECONDARY American Spinal Injury Association (ASIA) Total Score |
182.44; 178.39; 176.05; 172.00; 168.41; 163.80 | — |
| SECONDARY SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score |
28.93; 28.44; 27.56; 26.85; 26.05; 25.71 | — |
| SECONDARY International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score |
12; 11 | — |
| SECONDARY Penn Scale |
1; 1 | — |
| SECONDARY Modified Ashworth Scale |
2; 2; 2.5; 3 | — |
| SECONDARY Geffner Scale |
3; 2 | — |
| SECONDARY Neurogenic Bowel Dysfunction (NBD) Scale |
3; 6 | — |
| SECONDARY Residual Urine Volume |
27.90; 67.65 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02481440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.