Intraoperative ADSC Administration During Nerve Release

Mossakowski Medical Research Centre Polish Academy of Sciences6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neurotmesis of Peripheral Nerve (Disorder)

Interventions

ADSC administrationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Electrophysiological improvement

Improvement in EMG - the appearance of activities in denervated muscles

Time frame: 1 year

Data from ClinicalTrials.gov

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