Autologous Human Schwann Cells in Peripheral Nerve Repair

W. Dalton Dietrich

Status and phase

Active, not recruiting

Phase 1

Conditions

Peripheral Nerve Injuries

Treatments

Biological: autologous human Schwann cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03999424

20190453

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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;