Recruiting NCT05541250
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Human Schwann Cell.
- Who it may be relevant to
- Registry conditions: Peripheral Nerve Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Biological Autologous Human Schwann Cell
A one-time dose of 1000 μl\* or 80 to 100 million ahSC prepared from segments of the sural nerve from the leg recovered from the participant.
Primary outcome measures
- Incidence of Treatment-related Adverse Events (AEs) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- Motor Recovery as assessed using the MRC Grading Scale [Time frame: Up to 2 years]
- Sensory recovery as assessed by Pin-Prick Evaluation [Time frame: Up to 2 years]
- Sensory recovery as assessed by the 2-Point Discrimination Evaluation [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
- Between the ages of 18 and 65 at last birthday
Exclusion criteria
- Persons unable to safely undergo an MRI;
- Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- Persons with severe peripheral nerve injury gap length > 10 cm;
- Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
- Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
- Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
- History of active substance abuse;
- Persons allergic to gentamicin;
- Persons who test positive for HIV or Hepatitis B or C virus.
- Persons unable to provide consent independently due to cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT05541250 · 20220447 · OR210075