Brachial Plexus NeuropathiesBPI+MSCNCT04654286
Human Amniotic Membrane and Mesenchymal Stem Cells Composite
A study testing Nerve transfer procedure and Nerve transfer with HAM-AdMSC composite wrapping in people with Brachial Plexus Neuropathies, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
The purpose of this clinical trial is to investigate the utility of composite wrapping comprising human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) for augmentation of nerve transfer procedure in upper TBPI patients Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Neuropathies
- What is being tested?
- Nerve transfer procedure and Nerve transfer with HAM-AdMSC composite wrapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Nov 2016to 30 Jul 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Suffering from upper BPI (C5-C6 and/or C5-C7) for a duration of fewer than 12 months
- Have no systemic disease (Diabetes Mellitus, Lupus erythematosus, rheumatoid arthritis)
- Without prior medicamentous treatment history such as corticosteroids
- Agree to contribute in the study
Who cannot join
- Complete BPI (C5-Th1), lower BPI (C8-Th1)
- Traumatic BPI associated with delayed/non-union fracture of the upper extremity affected side.
- Polytrauma conditions which are not fully recovered
Trial locations and contacts
1 site in 1 country.
Heri Suroto, MD,PhD contact
Heri Suroto, MD,PhD contact
Indonesia1 site, 1 recruiting
- Recruiting
Cell and Tissue Bank - Regenerative Medicine, Dr. Soetomo General Academic Hospital/ Faculty of Medicine Universitas Airlangga
Surabaya, East Java, 60286
Heri Suroto, MD, PhD, hsuroto2000@yahoo.com
Heri Suroto, MD, PhD, heri-suroto@fk.unair.ac.id
About this study
Official title: Clinical Outcomes of Human Amniotic Membrane and Allogeneic Mesenchymal Stem Cells Composite Augmentation for Nerve Transfer Procedure in Brachial Plexus Injury Patients
The purpose of this clinical trial is to investigate the utility of composite wrapping comprising human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) for augmentation of nerve transfer procedure in upper TBPI patients
Read the detailed description
Nerve transfer procedure is recognized as the current gold standard for treating traumatic brachial plexus injury (TBPI). However, despite the current major progress in diagnosis and microsurgical repair, the prognosis in TBPI remains unfavorable due to limited donor nerve and compromised regenerative capability of the nervous system arising from prolonged denervation. Therefore, there is a major need to devise new treatment strategies; and one possible approach is to develop cellular therapies to bioengineer new nerve tissue and/or modulate the endogenous regenerative mechanisms within the injured nerve.
Our previous studies have shown that the peripheral nerve tissue engineering approach using human amniotic membrane seeded with allogeneic adipose-derived MSCs to augment axonal regeneration in nerve transfer of TBPI patient revealed promising functional recovery of the shoulder range of motion (ROM). The investigators plan a non-randomized clinical trial in a single center to investigate the use of a hybrid (composite) between human amniotic membrane (HAM) and allogeneic adipose-derived mesenchymal stem cells (AdMSC) as wrapping in the nerve transfer procedure of upper TBPI patients, with a focus on the augmentation of axonal regeneration
- Conditions
- Brachial Plexus Neuropathies
- Being tested
- Nerve transfer procedure, Nerve transfer with HAM-AdMSC composite wrapping
- Keywords
- Brachial Plexus Injury, Amniotic Membrane, Mesenchymal Stem Cells, Nerve Transfer
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve transfer procedureProcedure or surgery
- Identification of potential donor nerves: phrenic nerve, accessory nerve, intercostal nerve, motor branch nerve innervating long head of triceps muscle, motor branch of ulnar nerve innervating flexor carpi ulnaris (FCU) muscle, and motor branch of median nerve innervating flexor carpi radialis (FCR) muscle.
- Donor nerve is checked for its viability with an electric stimulator during surgery
- Viable donor nerve is dissected, transferred to the recipient area, and sutured with end-to-end anastomosis.
Nerve transfer with HAM-AdMSC composite wrappingProcedure or surgery
When the nerve transfer procedure is finished, the end-to-end anastomosis is wrapped by a composite consisted of human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC)
| Study group | Role | What they receive |
|---|---|---|
| Control group (Nerve transfer procedure) | Active comparator | Patient will receive nerve transfer procedure without augmentation Receives: Procedure: Nerve transfer procedure |
| Experimental group (Nerve transfer with HAM-AdMSC composite wrapping) | Experimental | Following nerve transfer procedure, the end-to-end anastomosis will be wrapped with HAM-AdMSC composite as augmentation Receives: Procedure: Nerve transfer with HAM-AdMSC composite wrapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion (AROM) pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Measured: Pre-surgery
Active range of motion (AROM) at 12 months follow-up
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Measured: 12 months
Functional motor power outcome pre-surgery
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
Measured: Pre-surgery
Functional motor power outcome at 12 months follow-up
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
Measured: 12 months
Secondary outcomes (8)
Initial elbow flexion MRC grade 1 (in months)
Measurement of the length of time (in months) for the patients to show initial contraction (achieve MRC grade 1) of elbow flexion. Previous study by Estrella (2011) showed that the average time for brachial plexus injury patients to achieve an elbow flexion grade M3 after nerve transfer procedure was 7.6 months (range, 5-12 months). As the elbow flexion is the most important movement to restore in treating BPI, the investigators aim to compare the length of time (in months) for the patients to achieve initial contraction (MRC grade 1). The sooner the patients achieve initial elbow flexion MRC grade 1, the better the outcome is.
Measured: throughout the study duration (12 months), recorded as the first time reported by the patients
Initial elbow flexion MRC grade 3 (in months)
Measurement of the length of time (in months) for the patients to achieve MRC grade 3 (active movement against gravity) of elbow flexion. Previous study by Estrella (2011) showed that the average time for brachial plexus injury patients to achieve an elbow flexion grade M3 after nerve transfer procedure was 7.6 months (range, 5-12 months). As the elbow flexion is the most important movement to restore in treating BPI, the investigators aim to compare the length of time (in months) for the patients to achieve MRC grade 3. The sooner the patients achieve initial elbow flexion MRC grade 3, the better the outcome is.
Measured: throughout the study duration (12 months), recorded as the first time reported by the patients
Pain outcome pre-surgery
Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating worst, unbearable pain). The lower scores mean a better pain outcome.
Measured: Pre-surgery
Pain outcome at 12 months follow-up
Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating the worst, unbearable pain). The lower scores mean a better pain outcome.
Measured: 12 months
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Measured: pre-surgery
Disabilities of the Arm, Shoulder, and Hand (DASH) score at 12 months follow-up
DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Measured: 12 months
Short Form-36 (SF-36) score pre-surgery
A generic, multipurpose, short-form health survey comparing the relative burden of diseases consisting of 36 questions which cover eight domains of health namely physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A higher score indicating a more favourable health state/quality of life (better outcome).
Measured: pre-surgery
Short Form-36 (SF-36) score at 12 months follow-up
A generic, multipurpose, short-form health survey comparing the relative burden of diseases consisting of 36 questions which cover eight domains of health namely physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A higher score indicating a more favourable health state/quality of life (better outcome).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start17 Nov 2016
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus NeuropathiesStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Heri Suroto, MD,PhD, Principal investigator, Dr. Soetomo General Academic Hospital/ Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654286
- Sponsor's protocol ID
- 647 / Panke.KKE/ XI / 2016
- Acronym
- BPI+MSC
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Human Amniotic Membrane and Allogeneic Mesenchymal Stem Cells Composite Augmentation for Nerve Transfer Procedure in Brachial Plexus Injury Patients
- ClinicalTrials.gov ID
- NCT04654286
- Acronym / sponsor ID
- BPI+MSC / 647 / Panke.KKE/ XI / 2016
- Conditions
- Brachial Plexus Neuropathies
- Keywords
- Brachial Plexus Injury, Amniotic Membrane, Mesenchymal Stem Cells, Nerve Transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 4 Dec 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 purpose of this clinical trial is to investigate the utility of composite wrapping comprising human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) for augmentation of nerve transfer procedure in upper TBPI patients
Detailed description
Nerve transfer procedure is recognized as the current gold standard for treating traumatic brachial plexus injury (TBPI). However, despite the current major progress in diagnosis and microsurgical repair, the prognosis in TBPI remains unfavorable due to limited donor nerve and compromised regenerative capability of the nervous system arising from prolonged denervation. Therefore, there is a major need to devise new treatment strategies; and one possible approach is to develop cellular therapies to bioengineer new nerve tissue and/or modulate the endogenous regenerative mechanisms within the injured nerve.
Our previous studies have shown that the peripheral nerve tissue engineering approach using human amniotic membrane seeded with allogeneic adipose-derived MSCs to augment axonal regeneration in nerve transfer of TBPI patient revealed promising functional recovery of the shoulder range of motion (ROM). The investigators plan a non-randomized clinical trial in a single center to investigate the use of a hybrid (composite) between human amniotic membrane (HAM) and allogeneic adipose-derived mesenchymal stem cells (AdMSC) as wrapping in the nerve transfer procedure of upper TBPI patients, with a focus on the augmentation of axonal regeneration
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Nerve transfer procedure) | Active comparator | Procedure: Nerve transfer procedurePatient will receive nerve transfer procedure without augmentation |
| Experimental group (Nerve transfer with HAM-AdMSC composite wrapping) | Experimental | Procedure: Nerve transfer with HAM-AdMSC composite wrappingFollowing nerve transfer procedure, the end-to-end anastomosis will be wrapped with HAM-AdMSC composite as augmentation |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Suffering from upper BPI (C5-C6 and/or C5-C7) for a duration of fewer than 12 months
- Have no systemic disease (Diabetes Mellitus, Lupus erythematosus, rheumatoid arthritis)
- Without prior medicamentous treatment history such as corticosteroids
- Agree to contribute in the study
Key exclusion criteria (3 listed)
- Complete BPI (C5-Th1), lower BPI (C8-Th1)
- Traumatic BPI associated with delayed/non-union fracture of the upper extremity affected side.
- Polytrauma conditions which are not fully recovered
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 |
|---|---|---|
| Nerve transfer procedure1. Identification of potential donor nerves: phrenic nerve, accessory nerve, intercostal nerve, motor branch nerve innervating long head of triceps muscle, motor branch of ulnar nerve innervating flexor carpi ulnaris (FCU) muscle, and motor branch of median nerve innervating flexor carpi radialis (FCR) muscle. 2. Donor nerve is checked for its viability with an electric stimulator during surgery 3. Viable donor nerve is dissected, transferred to the recipient area, and sutured with end-to-end anastomosis. | Procedure or surgery | Control group (Nerve transfer procedure) |
| Nerve transfer with HAM-AdMSC composite wrappingWhen the nerve transfer procedure is finished, the end-to-end anastomosis is wrapped by a composite consisted of human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) | Procedure or surgery | Experimental group (Nerve transfer with HAM-AdMSC composite wrapping) |
Primary outcome
Active range of motion (AROM) pre-surgery
Time frame: Pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Active range of motion (AROM) at 12 months follow-up
Time frame: 12 months
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Functional motor power outcome pre-surgery
Time frame: Pre-surgery
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
Functional motor power outcome at 12 months follow-up
Time frame: 12 months
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
8 secondary outcomes
Initial elbow flexion MRC grade 1 (in months)
Time frame: throughout the study duration (12 months), recorded as the first time reported by the patients
Initial elbow flexion MRC grade 3 (in months)
Time frame: throughout the study duration (12 months), recorded as the first time reported by the patients
Pain outcome pre-surgery
Time frame: Pre-surgery
Pain outcome at 12 months follow-up
Time frame: 12 months
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
Time frame: pre-surgery
Disabilities of the Arm, Shoulder, and Hand (DASH) score at 12 months follow-up
Time frame: 12 months
Short Form-36 (SF-36) score pre-surgery
Time frame: pre-surgery
Short Form-36 (SF-36) score at 12 months follow-up
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
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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.
Heri Suroto, MD,PhD contact
Heri Suroto, MD,PhD contact
Heri Suroto, MD,PhD principal investigator
Dr. Soetomo General Academic Hospital/ Universitas Airlangga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve transfer procedure and Nerve transfer with HAM-AdMSC composite wrapping in people with Brachial Plexus Neuropathies, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 3 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 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Heri Suroto, MD,PhD (hsuroto2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion (AROM) pre-surgery (time frame: Pre-surgery). The study lists 4 primary outcomes in all. 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 7 Dec 2020.