NCT03308565: CELLTOP

Adipose Stem Cells for Traumatic Spinal Cord Injury

Completed Phase 1 Last updated 30 August 2022

What this trial tests

Phase 1 trial testing Autologous, Adipose derived Mesenchymal Stem Cells in Spinal Cord Injuries in 10 participants. Completed in 11 October 2021.

Timeline

5 December 2017

Primary endpoint
22 October 2019

11 October 2021

Quick facts

Lead sponsor	Mohamad Bydon
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	5 December 2017
Primary completion	22 October 2019
Estimated completion	11 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Autologous, Adipose derived Mesenchymal Stem Cells — full drug profile →

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Paralysis — all drugs for Paralysis →

Sponsor

Mohamad Bydon

Who can join

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

Sponsor's own description

The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.

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. 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
3. 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
4. Mesenchymal stem cell secretome and extracellular vesicles for neurodegenerative diseases: Risk-benefit profile and next steps for the market access.
   Giovannelli L, Bari E, Jommi C, Tartara F, et al · · 2023 · cited 81× · PMID 37456581 · DOI 10.1016/j.bioactmat.2023.06.013
5. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury.
   Bydon M, Dietz AB, Goncalves S, Moinuddin FM, et al · · 2020 · cited 66× · PMID 31785831 · DOI 10.1016/j.mayocp.2019.10.008
6. Adipose Stem Cell Translational Applications: From Bench-to-Bedside.
   Argentati C, Morena F, Bazzucchi M, Armentano I, et al · · 2018 · cited 63× · PMID 30400641 · DOI 10.3390/ijms19113475
7. Stem Cells Therapy for Spinal Cord Injury: An Overview of Clinical Trials.
   Silvestro S, Bramanti P, Trubiani O, Mazzon E. · · 2020 · cited 61× · PMID 31963888 · DOI 10.3390/ijms21020659
8. 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