## Protocol Section
### Identification Module
**NCT ID:** NCT02510079

**Brief Title:** Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.

**Official Title:** Emergent Expanded Access to Use Autologous Human Schwann Cell Augmentation of Nerve Autograft Repair in a Single Patient With Severe Peripheral Nerve Injury

#### Organization Study ID Info
**ID:** 20150501
#### Organization
**Class:** OTHER
**Full Name:** University of Miami
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-16

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-15

**Overall Status:** NO_LONGER_AVAILABLE

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2015-07-28
**Type:** ESTIMATED
**Study First Submit Date:** 2015-07-15
**Study First Submit QC Date:** 2015-07-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** The Miami Project to Cure Paralysis

#### Lead Sponsor

**Class:** OTHER

**Name:** W. Dalton Dietrich

#### Responsible Party

**Investigator Affiliation:** University of Miami

**Investigator Full Name:** W. Dalton Dietrich

**Investigator Title:** Professor of Neurosurgery

**Type:** SPONSOR_INVESTIGATOR

### Description Module

**Brief Summary:** The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.

**Detailed Description:** The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested from a relatively small segment of sensory nerve. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

### Conditions Module

**Conditions:**

- Sciatic Nerve Injury

### Design Module

**Study Type:** EXPANDED_ACCESS

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Schwann cells harvested from the sural nerve will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).

**Name:** Autologous human Schwann cells

**Type:** BIOLOGICAL

### Eligibility Module

**Eligibility Criteria:** Single patient with severe sciatic nerve injury enrolled under emergency request

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Miami

**Country:** United States

**Facility:** University of Miami

**State:** Florida

**Zip:** 33136

#### Overall Officials

**Official 1:**

**Affiliation:** University of Miami

**Name:** W. Dalton Dietrich, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29440

- Name: Peripheral Nerve Injuries

- Relevance: HIGH

- As Found: Peripheral Nerve Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059348

- Term: Peripheral Nerve Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: LOW

- As Found: Unknown

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
