Injury of Facial Nerve, Unspecified Side, Initial EncounterEarly Phase 1NCT02853942
Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm
A Early Phase 1 study testing Autologous adipose stem cell therapy and Mecobalamin in people with Injury of Facial Nerve, Unspecified Side, Initial Encounter, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Injury of Facial Nerve, Unspecified Side, Initial Encounter
- What is being tested?
- Autologous adipose stem cell therapy and Mecobalamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age of 18 ~ 80 years old;
- no surgical contraindications, accept facial nerve microvascular decompression surgery;
- to enter into the group's informed consent and sign the consent form for clinical research.
- patients with preoperative facial nerve electrophysiology examination without facial paralysis
- patients with preoperative electrical testing without hearing impairment
Who cannot join
- patients with poor compliance;
- major surgical complications and interruption of treatment;
- brain magnetic resonance examination or blood test results abnormal and clinical significance;
- clinical trials of other drugs within 30 days;
- the unintended side effects;
About this study
Official title: The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.
Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery.
Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.
Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design：Single center, prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index Evaluation of therapeutic effect：Facial nerve function evaluation (House-Brackmann classification, facial nerve function classification scale SFGS), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.
- Being tested
- Autologous adipose stem cell therapy, Mecobalamin
- Medical subject headings
- Facial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose stem cell therapyBiological
MecobalaminDrug
| Study group | Role | What they receive |
|---|---|---|
| Stem cell therapy group | Experimental | Using the international standard 14G (diameter 1.54mm) needle inject autologous adipose derived mesenchymal stem cells 2ml to facial nerve, the effective release of the concentration is 100 million stem cells / ml. Receives: Biological: Autologous adipose stem cell therapy; Drug: Mecobalamin |
| Neurotrophic drugs treatment group | Experimental | Patients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient Receives: Drug: Mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann facial nerve grading scale
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Facial Nerve, Unspecified Side, Initial EncounterStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiting Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853942
- Sponsor's protocol ID
- XH-16-012
- Status last verified
- Aug 2016
- First submitted
- 14 Jul 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.
- ClinicalTrials.gov ID
- NCT02853942
- Acronym / sponsor ID
- XH-16-012
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- 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.
Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery.
Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.
Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design：Single center, prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index Evaluation of therapeutic effect：Facial nerve function evaluation (House-Brackmann classification, facial nerve function classification scale SFGS), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell therapy group | Experimental | Biological: Autologous adipose stem cell therapy, Drug: MecobalaminUsing the international standard 14G (diameter 1.54mm) needle inject autologous adipose derived mesenchymal stem cells 2ml to facial nerve, the effective release of the concentration is 100 million stem cells / ml. |
| Neurotrophic drugs treatment group | Experimental | Drug: MecobalaminPatients were treated with routine drug therapy，do not inject stem cell to the facial nerve of patient |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the age of 18 ~ 80 years old;
- no surgical contraindications, accept facial nerve microvascular decompression surgery;
- to enter into the group's informed consent and sign the consent form for clinical research.
- patients with preoperative facial nerve electrophysiology examination without facial paralysis
- patients with preoperative electrical testing without hearing impairment
Key exclusion criteria (5 listed)
- patients with poor compliance;
- major surgical complications and interruption of treatment;
- brain magnetic resonance examination or blood test results abnormal and clinical significance;
- clinical trials of other drugs within 30 days;
- the unintended side effects;
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 |
|---|---|---|
| Autologous adipose stem cell therapy | Biological | Stem cell therapy group |
| Mecobalamin | Drug | Neurotrophic drugs treatment group, Stem cell therapy group |
Primary outcome
House-Brackmann facial nerve grading scale
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Yes
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 Early Phase 1 study testing Autologous adipose stem cell therapy and Mecobalamin in people with Injury of Facial Nerve, Unspecified Side, Initial Encounter, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 5 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 9 Aug 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
House-Brackmann facial nerve grading scale (time frame: up to 3 months). 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 9 Aug 2016.