Intraoperative ADSC Administration During Nerve Release (NEUROASC)

April 14, 2020 updated by: Anna Sarnowska, Mossakowski Medical Research Centre Polish Academy of Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mossakowski Medical Research Centre Polish Academy of Sciences

Collaborators

Centre of Postgraduate Medical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2014

Primary Completion (Actual)

August 23, 2019

Study Completion (Anticipated)

June 23, 2022

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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