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Cell Therapy
Autologous Schwann Cell Therapy for Peripheral Nerve Injury
Phase 1
Recruiting
Research Sponsored by W. Dalton Dietrich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing whether it's safe to inject a person's own Schwann cells along with nerve auto-graft after a major nerve injury.
Who is the study for?
This trial is for adults aged 18-65 who have had a severe nerve injury in the past year, such as sciatic or brachial plexus injuries. It's not for pregnant women, those with certain pre-existing conditions, allergies to gentamicin, HIV/Hepatitis B/C, cognitive impairments that prevent consent, or if the nerve gap is over 10 cm.Check my eligibility
What is being tested?
The study tests injecting patients' own Schwann cells into their injured nerves alongside a standard nerve grafting procedure. The goal is to see if this approach improves recovery from severe peripheral nerve injuries.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site and complications related to cell transplantation. Since it involves one's own cells and surgery, risks associated with surgical procedures also apply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-related Adverse Events (AEs)
Secondary outcome measures
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 Design
1Treatment groups
Experimental Treatment
Group I: Autologous Human Schwann Cell (ahSC) GroupExperimental Treatment1 Intervention
Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant
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Who is running the clinical trial?
W. Dalton DietrichLead Sponsor
6 Previous Clinical Trials
27 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,602 Total Patients Enrolled
W. Dalton Dietrich, MDStudy ChairUniversity of Miami
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer or radiation treatment in the area where my nerve was injured.I do not have conditions that would prevent safe nerve tissue collection.I am not pregnant nor planning to become pregnant during the trial.I have had a major nerve injury in my arms or legs within the last year.I cannot give consent on my own due to cognitive issues.I do not have any health conditions that could affect my safety or participation in the study.I am between 18 and 65 years old.I cannot safely have an MRI scan.I have had a severe nerve injury in my arm or leg in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Autologous Human Schwann Cell (ahSC) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Autologous Human Schwann Cell currently endorsed by the FDA?
"Based on the available evidence, our team at Power concluded that Autologous Human Schwann Cell is safe and assigned it a score of 1. As this is only a Phase 1 trial, there are limited data points to back up its efficacy and safety."
Answered by AI
Is the enrollment phase of this experiment still taking place?
"As indicated on clinicaltrials.gov, the initial posting of this medical trial occurred 12/20/2022 and was last amended 11/14/2020; thus, it is not presently recruiting participants. However, there are 745 other studies actively seeking volunteers currently."
Answered by AI
Is it possible to partake in this research endeavor?
"Eligible participants for this trial must have peripheral nerves and be between 18 to 65 years of age. Currently, the study is accepting a maximum of 30 enrollees."
Answered by AI
Does this trial accept adult participants who are over 45 years of age?
"The eligibility criterion for this medical research requires that participants are of legal age and under the retirement threshold."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Florida
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Miami
How many prior treatments have patients received?
3+
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