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Spinal Cord Injury - Healing Genes
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Spinal Cord Injury

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Adipose Stem Cells for Traumatic Spinal Cord Injury (CELLTOP)

Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury


Phase 1

DESCRIPTION:

Doctors at the Mayo Clinic in MN are recruiting patients with spinal cord injuries to trial an investigatory treatment using adipose (fat)-derived mesenchymal stem cells (AD-MSCs). The researchers hope these regenerative cells may improve sensory and motor function. They will be drawn via liposuction procedure, processed in a lab, then delivered intrathecally (into the spine). Patients will then be evaluated at day 2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.


PATIENT MUST:

  • Be 18 years of age and older
  • Have a spinal cord injury (SCI) which must be traumatic, blunt/non-penetrating in nature and not degenerative
  • Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle.

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate.
  2. Adipose tissue is obtained from the patient and processed in a lab.
  3. The stem cells are injected intrathecally (into the spine).
  4. Patients will then be evaluated at day 2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.

LOCATIONS AND CONTACTS:

Trials will take place at the Mayo Clinic in Rochester in Rochester, MN, Map.

Contacts:

Bambi L Wessel  |  (507) 293-1963  |  [email protected]

Sandy Goncalves, MS  |  (507) 538-6546  |  [email protected]

 

SPONSOR INFORMATION:

Allan Dietz

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03308565

 

 

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