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NCT02481440

Repeated Subarachnoid Administrations of hUC-MSCs in Treating SCI

Completed Phase 1, PHASE2 Results posted Last updated 30 June 2020
What this trial tests

Phase 1, PHASE2 trial testing human umbilical cord mesenchymal stem cells (hUC-MSCs) in Spinal Cord Injuries in 102 participants. Completed in 31 March 2020.

Timeline
30 March 2018
Primary endpoint
31 March 2020
31 March 2020

Quick facts

Lead sponsorLimin Rong
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment102
Start date30 March 2018
Primary completion31 March 2020
Estimated completion31 March 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Limin Rong

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

American Spinal Injury Association (ASIA) Total Score at the Fourth Follow-up Primary · 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.

GroupValue95% CI
hUC-MSC Transplantation183.88± 69.76
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score at the Fourth Follow-up Primary · 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.

GroupValue95% CI
hUC-MSC Transplantation29.49± 10.47
American Spinal Injury Association (ASIA) Total Score Secondary · 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.

3rd follow-up
GroupValue95% CI
hUC-MSC Transplantation182.44± 71.00
2nd follow-up
GroupValue95% CI
hUC-MSC Transplantation178.39± 71.51
1st follow-up
GroupValue95% CI
hUC-MSC Transplantation176.05± 71.88
4th transplantation
GroupValue95% CI
hUC-MSC Transplantation172.00± 73.51
3rd transplantation
GroupValue95% CI
hUC-MSC Transplantation168.41± 74.16
2nd transplantation
GroupValue95% CI
hUC-MSC Transplantation163.80± 72.53
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation158.15± 70.93
SCI Functional Rating Scale of the International Association of Neurorestoratology (IANR-SCIFRS) Total Score Secondary · 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.

3rd follow-up
GroupValue95% CI
hUC-MSC Transplantation28.93± 10.26
2nd follow-up
GroupValue95% CI
hUC-MSC Transplantation28.44± 10.28
1st follow-up
GroupValue95% CI
hUC-MSC Transplantation27.56± 10.03
4th transplantation
GroupValue95% CI
hUC-MSC Transplantation26.85± 10.36
3rd transplantation
GroupValue95% CI
hUC-MSC Transplantation26.05± 10.15
2nd transplantation
GroupValue95% CI
hUC-MSC Transplantation25.71± 10.32
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation24.54± 9.82
International Standards to Document Remaining Autonomic Function After Spinal Cord Injury (ISAFSCI) Score Secondary · 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.

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation1211 – 14
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation1110 – 12
Penn Scale Secondary · 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.

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation10 – 2
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation10 – 3
Modified Ashworth Scale Secondary · 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.

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation20 – 4
2nd follow-up
GroupValue95% CI
hUC-MSC Transplantation20 – 4
1st follow-up
GroupValue95% CI
hUC-MSC Transplantation2.50 – 4.5
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation30 – 6
Geffner Scale Secondary · 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.

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation32 – 4
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation20 – 4
Neurogenic Bowel Dysfunction (NBD) Scale Secondary · 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.

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation32 – 10
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation62 – 12.5
Residual Urine Volume Secondary · at first transplantation and 12 months following the final administration of hUC-MSCs

Ultrasonic examination is used to assess residual urine volume

4th follow-up
GroupValue95% CI
hUC-MSC Transplantation27.908.83 – 88.50
1st transplantation
GroupValue95% CI
hUC-MSC Transplantation67.6531.58 – 144.50

Adverse events — posted to ClinicalTrials.gov

Time frame: During the intervention and follow-up periods of this trial, up to 16 months, any AE was identified and collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

hUC-MSC Transplantation
Serious: 0/102 (0%)
Deaths: 0/102
Other adverse events (4 terms — click to expand)

ReactionSystemhUC-MSC Transplantation
feverImmune system disorders—
headacheNervous system disorders—
dizzinessNervous system disorders—
transient increase of muscle tensionNervous system disorders—

Data from ClinicalTrials.gov NCT02481440 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Challenges and advances in clinical applications of mesenchymal stromal cells.
    Zhou T, Yuan Z, Weng J, Pei D, et al · · 2021 · cited 489× · PMID 33579329 · DOI 10.1186/s13045-021-01037-x
  2. Concise Review: Bridging the Gap: Novel Neuroregenerative and Neuroprotective Strategies in Spinal Cord Injury.
    Ahuja CS, Fehlings M. · · 2016 · cited 160× · PMID 27130222 · DOI 10.5966/sctm.2015-0381
  3. The leading edge: Emerging neuroprotective and neuroregenerative cell-based therapies for spinal cord injury.
    Ahuja CS, Mothe A, Khazaei M, Badhiwala JH, et al · · 2020 · cited 102× · PMID 32691994 · DOI 10.1002/sctm.19-0135
  4. Differentiation of Human Mesenchymal Stem Cells towards Neuronal Lineage: Clinical Trials in Nervous System Disorders.
    Hernández R, Jiménez-Luna C, Perales-Adán J, Perazzoli G, et al · · 2020 · cited 95× · PMID 31649208 · DOI 10.4062/biomolther.2019.065
  5. Comparing the Therapeutic Potential of Stem Cells and their Secretory Products in Regenerative Medicine.
    Foo JB, Looi QH, Chong PP, Hassan NH, et al · · 2021 · cited 89× · PMID 34422061 · DOI 10.1155/2021/2616807
  6. Mesenchymal stem cells in the treatment of spinal cord injury: Mechanisms, current advances and future challenges.
    Xia Y, Zhu J, Yang R, Wang H, et al · · 2023 · cited 57× · PMID 36911700 · DOI 10.3389/fimmu.2023.1141601
  7. Regulation of Inflammatory Cytokines for Spinal Cord Injury Repair Through Local Delivery of Therapeutic Agents.
    Ren H, Chen X, Tian M, Zhou J, et al · · 2018 · cited 54× · PMID 30479916 · DOI 10.1002/advs.201800529
  8. Pharmacokinetic characteristics of mesenchymal stem cells in translational challenges.
    Shan Y, Zhang M, Tao E, Wang J, et al · · 2024 · cited 47× · PMID 39271680 · DOI 10.1038/s41392-024-01936-8

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