Clinical trial NCT03999424: Autologous Human Schwann Cells in Peripheral Nerve Repair
Official title: The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Peripheral Nerve Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Miami Project to Cure Paralysis
First posted: 2019-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.


Eligibility criteria: Inclusion Criteria:

* Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
* Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
* Between the ages of 18 and 65 years at last birthday;

Exclusion Criteria:

* Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
* Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
* Persons with severe peripheral nerve injury gap length \> 10 cm in length;
* 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 transplantation;
* 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;

Primary outcomes:
measure: Number of participants with reported adverse events (AEs)
timeFrame: 12 months post-transplantation
measure: Number of participants with reported cell product culture test failure
timeFrame: 12 months post-transplantation
measure: Change in muscle strength scale grade of affected limb muscles
timeFrame: from baseline to 12 months post-transplantation
measure: Sensory recovery scale grade of affected dermatomes
timeFrame: from baseline to 12 months post-transplantation
measure: Change in pain scores
timeFrame: from baseline to 12 months post-transplantation
measure: Change in pain characteristics (location, intensity, and description)
timeFrame: from baseline to 12 months post-transplantation
measure: Number of participants with reported tumorigenesis or unexpected changes in nerve structure
timeFrame: 2 years post-transplantation
Secondary outcomes:
measure: Change in muscle strength scale grade of affected limb muscles
timeFrame: from baseline to 5 years
measure: Sensory recovery scale grade of affected dermatomes
timeFrame: from baseline to 5 years
measure: Change in pain scores
timeFrame: from baseline to 5 years post-transplantation
measure: Change in pain characteristics (location, intensity, and description)
timeFrame: from baseline to 5 months post-transplantation
measure: Nerve-graft continuity
timeFrame: 2 weeks post-transplantation
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Allan Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: