Autologous Human Schwann Cells in Peripheral Nerve Repair

Peripheral Nerve Injuries Clinical Trial

Official title:

The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03999424
• Other study ID #: 20190453
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 24, 2019
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Peripheral Nerve Injuries

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
W. Dalton Dietrich	The Miami Project to Cure Paralysis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with reported adverse events (AEs)	The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.	12 months post-transplantation
Primary	Number of participants with reported cell product culture test failure	Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.	12 months post-transplantation
Primary	Change in muscle strength scale grade of affected limb muscles	The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.	from baseline to 12 months post-transplantation
Primary	Sensory recovery scale grade of affected dermatomes	Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.	from baseline to 12 months post-transplantation
Primary	Change in pain scores	The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.	from baseline to 12 months post-transplantation
Primary	Change in pain characteristics (location, intensity, and description)	Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.	from baseline to 12 months post-transplantation
Primary	Number of participants with reported tumorigenesis or unexpected changes in nerve structure	Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).	2 years post-transplantation
Secondary	Change in muscle strength scale grade of affected limb muscles	The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.	from baseline to 5 years
Secondary	Sensory recovery scale grade of affected dermatomes	Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.	from baseline to 5 years
Secondary	Change in pain scores	The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.	from baseline to 5 years post-transplantation
Secondary	Change in pain characteristics (location, intensity, and description)	Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.	from baseline to 5 months post-transplantation
Secondary	Nerve-graft continuity	Ultrasound will be used to assess nerve-graft continuity.	2 weeks post-transplantation