Clinical trial
The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Name
20190453
Description
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.
Trial arms
Trial start
2019-09-24
Estimated PCD
2025-09-01
Trial end
2025-09-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
autologous human Schwann cells
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
Arms:
Autologous human Schwann cells
Size
10
Primary endpoint
Number of participants with reported adverse events (AEs)
12 months post-transplantation
Number of participants with reported cell product culture test failure
12 months post-transplantation
Change in muscle strength scale grade of affected limb muscles
from baseline to 12 months post-transplantation
Sensory recovery scale grade of affected dermatomes
from baseline to 12 months post-transplantation
Change in pain scores
from baseline to 12 months post-transplantation
Change in pain characteristics (location, intensity, and description)
from baseline to 12 months post-transplantation
Number of participants with reported tumorigenesis or unexpected changes in nerve structure
2 years post-transplantation
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-10-23
1 organization
1 product
1 indication
Organization
W. Dalton DietrichIndication
Peripheral Nerve Injuries