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Intraoperative ADSC Administration During Nerve Release (NEUROASC)

Primary Purpose

Neurotmesis of Peripheral Nerve (Disorder)

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ADSC administration

About this trial

This is an interventional treatment trial for Neurotmesis of Peripheral Nerve (Disorder) focused on measuring ADSC, nerve release, neurolysis, stem cells, scar, peripheral nerves

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Outcomes

Primary Outcome Measures

Electrophysiological improvement

Improvement in EMG - the appearance of activities in denervated muscles

Secondary Outcome Measures

Full Information

NCT ID

NCT04346680

First Posted

October 15, 2019

Last Updated

April 14, 2020

Sponsor

Mossakowski Medical Research Centre Polish Academy of Sciences

Collaborators

Centre of Postgraduate Medical Education

1. Study Identification

Unique Protocol Identification Number

NCT04346680

Brief Title

Intraoperative ADSC Administration During Nerve Release

Acronym

NEUROASC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 23, 2014 (Actual)

Primary Completion Date

August 23, 2019 (Actual)

Study Completion Date

June 23, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mossakowski Medical Research Centre Polish Academy of Sciences

Collaborators

Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurotmesis of Peripheral Nerve (Disorder)

Keywords

ADSC, nerve release, neurolysis, stem cells, scar, peripheral nerves

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

ADSC administration

Intervention Description

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.

Primary Outcome Measure Information:

Title

Electrophysiological improvement

Description

Improvement in EMG - the appearance of activities in denervated muscles

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

Intraoperative ADSC Administration During Nerve Release

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