Intraoperative ADSC Administration During Nerve Release

Not Applicable

• Conditions: Neurotmesis of Peripheral Nerve (Disorder)
• Interventions: Procedure: ADSC administration

• Registration Number: NCT04346680
• Lead Sponsor: Mossakowski Medical Research Centre Polish Academy of Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-04-23
• Primary Completion: 2019-08-23
• Study First Submitted: 2019-10-15
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-15
• Study Completion: 2022-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	ADSC administration	-

Primary Outcome Measures

Name	Time	Method
Electrophysiological improvement	1 year	Improvement in EMG - the appearance of activities in denervated muscles