Intraoperative ADSC Administration During Nerve Release (NEUROASC)

Mossakowski Medical Research Centre Polish Academy of Sciences

Status: Unknown

Conditions: Neurotmesis of Peripheral Nerve (Disorder)

Treatments: Procedure: ADSC administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04346680

11/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Procedure: ADSC administration