Neurotmesis of Peripheral Nerve (Disorder)NEUROASCNCT04346680
Intraoperative ADSC Administration During Nerve Release
A study testing ADSC administration in people with Neurotmesis of Peripheral Nerve (Disorder), run by Mossakowski Medical Research Centre Polish Academy of Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Neurotmesis of Peripheral Nerve (Disorder)
- What is being tested?
- ADSC administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2014to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically definite failure nerve reconstructed patients
- lack of improvement after previous treatment
- without severe, unstable chronic diseases
- Polish citizens
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- ADSC administration
- Keywords
- ADSC, nerve release, neurolysis, stem cells, scar, peripheral nerves
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADSC administrationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Procedure: ADSC administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological improvement
Improvement in EMG - the appearance of activities in denervated muscles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start23 Apr 2014
- Primary completion23 Aug 2019
- Study completion23 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotmesis of Peripheral Nerve (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mossakowski Medical Research Centre Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Principal investigator, Anna Sarnowska, Mossakowski Medical Research Centre Polish Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346680
- Sponsor's protocol ID
- 11/2015
- Acronym
- NEUROASC
- Status last verified
- Apr 2020
- First submitted
- 15 Oct 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Adipose-Derived Stem Cells Administration During the Secondary Release (Neurolysis) of a Reconstructed Nerve
- ClinicalTrials.gov ID
- NCT04346680
- Acronym / sponsor ID
- NEUROASC / 11/2015
- Keywords
- ADSC, nerve release, neurolysis, stem cells, scar, peripheral nerves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Mossakowski Medical Research Centre Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- 23 Apr 2014 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Jun 2022 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: ADSC administration |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinically definite failure nerve reconstructed patients
- lack of improvement after previous treatment
- without severe, unstable chronic diseases
- Polish citizens
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADSC administrationThe 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. | Procedure or surgery | Experimental group |
Primary outcome
Electrophysiological improvement
Time frame: 1 year
Improvement in EMG - the appearance of activities in denervated muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ADSC administration in people with Neurotmesis of Peripheral Nerve (Disorder), run by Mossakowski Medical Research Centre Polish Academy of Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological improvement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.