Intraoperative ADSC Administration During Nerve Release

Neurotmesis of Peripheral Nerve (Disorder) Clinical Trial

— NEUROASC  

Official title:

Intraoperative Adipose-Derived Stem Cells Administration During the Secondary Release (Neurolysis) of a Reconstructed Nerve

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04346680
• Other study ID #: 11/2015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 23, 2014
• Est. completion date: June 23, 2022

Study information

• Verified date: April 2020
• Source: Mossakowski Medical Research Centre Polish Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the investigator's observational, nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal cells (ADSC) transplantation into the individuals with faiure in reconstruction of peripheral nerves. ADSC will be used during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. All enrolled patients will have a documented at least 2-years clinical and electrophisiological observation. Each patient will recive once 10 microinjections of ADSC along the injured nerve, directly after nerve neurolysis. Safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological (EMG, Sensory Thyreshold) and DASH survey.

Description:

The aim of the study will be an evaluation of undifferentiated Adipose-Derived Stromal/Stem Cells (ADSC) usage during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. Patients who experienced failure of nerve reconstruction will be included in the study. During the revisional surgery, nerve fascicles will be released, and ADSCs will be isolated from harvested fat with enzymatic method in a standarized conditions. Cells will be administered through microinjections along the fascicles and around the adjacent tissues after external neurolysis. The follow-up will be continued at least 36 months.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: June 23, 2022
• Est. primary completion date: August 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinically definite failure nerve reconstructed patients

• lack of improvement after previous treatment

• without severe, unstable chronic diseases

• Polish citizens

Exclusion Criteria:

• INR > 2 before liposuction

• primary haematological disease, including hypercoagulable states

• previous/current history of neoplasm or comorbidity that could impact upon patient's survival

• pregnancy /lactation

• alcohol abuse, cocaine amphetamine, etc.

Related Conditions & MeSH terms

• Neurotmesis of Peripheral Nerve (Disorder)
• Trauma, Nervous System

Intervention

Procedure:
• ADSC administration
The treated nerve will be identified and released. Scar tissue will be removed, and nerve fibers will be exposed. Prepared solutions of ADSC will be administered via microinjection with a 30-G needle along the released nerve fascicles, above and below the reconstructed area and around the adjacent tissue, which stayed in contact with the nerves.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mossakowski Medical Research Centre Polish Academy of Sciences	Centre of Postgraduate Medical Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrophysiological improvement	Improvement in EMG - the appearance of activities in denervated muscles	1 year