Autologous Human Schwann Cell for Peripheral Nerves

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Peripheral Nerves+2 More
Autologous Human Schwann Cell - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.

Eligible Conditions

  • Peripheral Nerves

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Incidence of Treatment-related Adverse Events (AEs)
Motor Recovery as assessed using the MRC Grading Scale
Sensory recovery as assessed by Pin-Prick Evaluation
Sensory recovery as assessed by the 2-Point Discrimination Evaluation

Trial Safety

Trial Design

1 Treatment Group

Autologous Human Schwann Cell (ahSC) Group
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Autologous Human Schwann Cell · No Placebo Group · Phase 1

Autologous Human Schwann Cell (ahSC) Group
Biological
Experimental Group · 1 Intervention: Autologous Human Schwann Cell · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
0 TrialsResearching Peripheral Nerves
620 CompletedClinical Trials

Who is running the clinical trial?

United States Department of DefenseFED
759 Previous Clinical Trials
202,130 Total Patients Enrolled
W. Dalton DietrichLead Sponsor
6 Previous Clinical Trials
27 Total Patients Enrolled
W. Dalton Dietrich, MDStudy ChairUniversity of Miami

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum nerve injury severity of at least T2 or T3.
You are between the ages of 18 and 65 at last birthday.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.