NCT03225625: SciExVR

Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

ENROLLING BY INVITATION NA Last updated 12 April 2024

What this trial tests

NA trial testing Paraspinal in Spinal Cord Injuries in 40 participants. Enrolling by invitation.

Timeline

1 July 2017

Primary endpoint
1 July 2025

1 July 2026

Quick facts

Lead sponsor	MD Stem Cells
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 July 2017
Primary completion	1 July 2025
Estimated completion	1 July 2026
Sites	1 location across United States

Drugs / interventions tested

• Paraspinal
• Paraspinal EX
• Paraspinal VR

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Spinal Cord Compression — all drugs for Spinal Cord Compression →
• Spinal Cord Ischemia — all drugs for Spinal Cord Ischemia →
• Spinal Cord Diseases — all drugs for Spinal Cord Diseases →

Sponsor

MD Stem Cells

Who can join

18 and older, any sex, with Spinal Cord Injuries or Spinal Cord Compression. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• American Spinal Injury Association (ASIA) Impairment Scale (AIS)
  Time frame: Pre-procedure, 1,3,6 and 12 months post-procedure
  AIS is based on the Frankel scale which is used to classify the degree or completeness of spinal cord injury (SCI) by assessing motor and sensory function. Patients will have AIS assessment prior to procedure and post-procedure for comparison and identification of any improvements in motor or sensory function.

Sponsor's own description

The SciExVR study will evaluate the potential benefit of autologous bone marrow derived stem cells (BMSC) in the treatment of spinal cord injury with evidence of impaired motor or sensory function. The treatment consists of bilateral paraspinal injections of the BMSC at the level of the injury as well as superior and inferior to that spinal segment followed by an intravenous injection and intranasal placement. Patients undergoing BMSC treatment may also be assigned to use of exoskeletal movement (or equivalent) or virtual reality visualization (or equivalent) to augment upper motor neuron firing and/or receptivity of the sensory neurons. http://mdstemcells.com/sciexvr/

Publications & conference data

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

1. Mesenchymal Stem Cells for Spinal Cord Injury: Current Options, Limitations, and Future of Cell Therapy
   Cofano F, Boido M, Monticelli M, Zenga F, et al · · 2019 · cited 265× · PMID 31159345 · DOI 10.3390/ijms20112698
2. Taking central nervous system regenerative therapies to the clinic: curing rodents <i>versus</i> nonhuman primates <i>versus</i> humans.
   Tsintou M, Dalamagkas K, Makris N. · · 2020 · cited 26× · PMID 31571651 · DOI 10.4103/1673-5374.266048
3. Conductive and injectable hyaluronic acid/gelatin/gold nanorod hydrogels for enhanced surgical translation and bioprinting.
   Kiyotake EA, Thomas EE, Homburg HB, Milton CK, et al · · 2022 · cited 18× · PMID 34390325 · DOI 10.1002/jbm.a.37294
4. On the Viability and Potential Value of Stem Cells for Repair and Treatment of Central Neurotrauma: Overview and Speculations.
   Wu S, FitzGerald KT, Giordano J. · · 2018 · cited 11× · PMID 30150968 · DOI 10.3389/fneur.2018.00602
5. Cell transplantation to repair the injured spinal cord.
   Hall A, Fortino T, Spruance V, Niceforo A, et al · · 2022 · cited 10× · PMID 36424097 · DOI 10.1016/bs.irn.2022.09.008
6. Stem Cell Clinical Trials in Spinal Cord Injury: A Brief Review of Studies in the United States.
   Platt A, David BT, Fessler ARG. · · 2020 · cited 8× · PMID 32408562 · DOI 10.3390/medicines7050027
7. Mesenchymal stromal cell therapies for traumatic neurological injuries.
   Wang X, Wang Q, Xia Z, Yang Y, et al · · 2024 · cited 5× · PMID 39578845 · DOI 10.1186/s12967-024-05725-3
8. Cell therapy for stroke and spinal cord injury in clinical trials.
   Fan Y, Wong ST, Goh ELK, Chan JKY. · · 2026 · PMID 41641797 · DOI 10.1093/stcltm/szaf082