NEUROASC: Intraoperative ADSC Administration During Nerve Release

Sponsor

Mossakowski Medical Research Centre Polish Academy of Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT04346680

Collaborator

Centre of Postgraduate Medical Education (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurotmesis of Peripheral Nerve (Disorder)	Procedure: ADSC administration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 23, 2014

Actual Primary Completion Date :

Aug 23, 2019

Anticipated Study Completion Date :

Jun 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	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.

Arm

Intervention/Treatment

Experimental: Experimental group

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.

Outcome Measures

Primary Outcome Measures

Electrophysiological improvement [1 year]
Improvement in EMG - the appearance of activities in denervated muscles

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mossakowski Medical Research Centre Polish Academy of Sciences
Centre of Postgraduate Medical Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Sarnowska, Head of Translational Platform for Regenerative Medicine MRC, Mossakowski Medical Research Centre Polish Academy of Sciences

ClinicalTrials.gov Identifier:

NCT04346680

Other Study ID Numbers:

11/2015

First Posted:

Apr 15, 2020

Last Update Posted:

Apr 15, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Anna Sarnowska, Head of Translational Platform for Regenerative Medicine MRC, Mossakowski Medical Research Centre Polish Academy of Sciences

Additional relevant MeSH terms:

Trauma, Nervous System

Study Results

No Results Posted as of Apr 15, 2020