Peripheral Nerve InjuriesNCT04465929
Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
A study testing Autologous Human Schwann Cells in people with Peripheral Nerve Injuries, run by W. Dalton Dietrich at 1 site in United States.
Trial summary
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI). Read more about this study
- Who is it for?
- Ages 16 to 16 years, women only
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Autologous Human Schwann Cells
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 16 years
- Women only
- Child
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Autologous Human Schwann Cells
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Human Schwann CellsBiological
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- W. Dalton Dietrich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W. Dalton Dietrich, University of Miami
- Investigators
- Allan D. Levi, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465929
- Sponsor's protocol ID
- 20190453-EAP
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
- ClinicalTrials.gov ID
- NCT04465929
- Acronym / sponsor ID
- 20190453-EAP
- Conditions
- Peripheral Nerve Injuries
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- W. Dalton DietrichUniversity, hospital or other
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).
Study design
Who may qualify
- Ages
- 16 to 16 years
- Sex
- Female only
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Human Schwann CellsSchwann 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 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan D. Levi, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Human Schwann Cells in people with Peripheral Nerve Injuries, run by W. Dalton Dietrich at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.