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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-related Adverse Events (AEs)
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
917 Previous Clinical Trials
334,669 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.