Intraoperative ADSC Administration During Nerve Release
NEUROASC
Intraoperative Adipose-Derived Stem Cells Administration During the Secondary Release (Neurolysis) of a Reconstructed Nerve
1 other identifier
interventional
6
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2019
CompletedFirst Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2022
CompletedApril 15, 2020
April 1, 2020
5.3 years
October 15, 2019
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Electrophysiological improvement
Improvement in EMG - the appearance of activities in denervated muscles
1 year
Study Arms (1)
Experimental group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- clinically definite failure nerve reconstructed patients
- lack of improvement after previous treatment
- without severe, unstable chronic diseases
- Polish citizens
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Translational Platform for Regenerative Medicine MRC
Study Record Dates
First Submitted
October 15, 2019
First Posted
April 15, 2020
Study Start
April 23, 2014
Primary Completion
August 23, 2019
Study Completion
June 23, 2022
Last Updated
April 15, 2020
Record last verified: 2020-04