Intraoperative ADSC Administration During Nerve Release

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Neurotmesis of Peripheral Nerve (Disorder)

Intervention / Treatment
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* Procedure: ADSC administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Procedure: ADSC administration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological improvement | Improvement in EMG - the appearance of activities in denervated muscles | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADSC, nerve release, neurolysis, stem cells, scar, peripheral nerves