Spinal Cord InjuriesPhase 1CELLTOPNCT03308565
Adipose Stem Cells for Traumatic Spinal Cord Injury
A Phase 1 study testing Autologous, Adipose derived Mesenchymal Stem Cells in people with Spinal Cord Injuries and Paralysis, run by Mohamad Bydon at 1 site in United States.
Trial summary
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Paralysis
- What is being tested?
- Autologous, Adipose derived Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 11 Oct 2021
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years and older
- Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal/barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
- Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- AIS grade A or B of SCI
- SCI must be traumatic, blunt/non-penetrating in nature and not degenerative
- SCI must be within two weeks and up to 1 year after the event
- Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments
- Once the nature of the study is fully explained and prior to any study-related procedure is initiated the subject is willing to provide written, informed consent and complete HIPAA documentation
Who cannot join
- Pregnant or nursing, or planning on becoming pregnant during the study period
- AIS grade of SCI other than A or B
- History of intra-spinal infection
- History of superficial infection in the index spinal level within 6 months of study
- Evidence of current superficial infection affecting the index spinal level at the time of enrollment
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids
Show all 18Show fewer
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis
- Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline
- Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater.
- Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine disease (e.g. diabetes, osteoporosis).
- History of malignancy including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion, or re-occurrence within three years of baseline). Any other malignancy will not be allowed.
- History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment
- Known allergy to local anesthetics of other components of the study drug
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
- History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or use of medical marijuana within 30 days of study entry
- Patients with baseline depression, diagnosed by the Beck Depression Inventory Assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
Read the detailed description
The proposed study is an open label, prospective Phase I safety and feasibility study of the intrathecal injection of autologous culture-expanded AD-MSCs in patients with severe traumatic spinal cord injury (SCI). All subjects will receive the same dosage of stem cells via intrathecal injection. Enrolled subjects will first undergo a minor surgical procedure in which a sample of the patient's adipose tissue will be harvested from a small incision in the patient's abdomen or thigh. The subject's adipose tissue will then be used to derive and culture-expand AD-MSCs for 4-6 weeks. Autologous AD-MSCs will be transplanted through intrathecal injection at the level of L4-5 under fluoroscopic guidance at a single dose of 100 million cells. Patients will be evaluated at set intervals following the injection: day 2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.
- Conditions
- Spinal Cord Injuries, Paralysis
- Being tested
- Autologous, Adipose derived Mesenchymal Stem Cells
- Keywords
- AIS grade A or B
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous, Adipose derived Mesenchymal Stem CellsBiological
The mesenchymal stem cells will be collected and expanded from the subjects adipose tissue.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Patients will receive a single dose of 100 million autologous, adipose derived mesenchymal stem cells. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery. Receives: Biological: Autologous, Adipose derived Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute adverse events
An adverse event is defined any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship to the study drug
Measured: up to 4 weeks post treatment
Secondary outcomes (21)
Incidence of delayed adverse events
An adverse event is defined any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship to the study drug.
Measured: 48 weeks post treatment
Severity of adverse events
The severity of adverse events will be graded into the following categories: mild, moderate, and severe.
Measured: 4 weeks post-treatment
Relationship of adverse events to study drug
The relationship of adverse events to study drug will be graded into the following categories: probable, possible, unlikely, unrelated.
Measured: 4 weeks post-treatment
Incidence of serious adverse events (SAE)
SAE is defined as adverse events that result in death, life threatening adverse experiences, hospitalization, new or prolonged disability/incapacity.
Measured: 48 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
The ASIA Impairment Scale describes a person's functional impairment (both motor and sensory) as a result of their spinal cord injury. The scale has 5 levels, ranging from A (complete) to E (normal).
Measured: baseline, 96 weeks
Change in sensory and motor function following completion of treatment as measured by motor evoked potentials (MEP)
Motor Evoked Potentials (MEP) are electrical responses recorded either from muscles, or from axons of the descending motor tract, in response to electrical or magnetic stimulation of nervous system structures that govern movement. While there are many different methods for stimulation and recording, the most common approach involves transcranial electrical stimulation of the motor pathway, using subdermal needle electrodes positioned in the scalp above primary motor cortex.
Measured: baseline, 96 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by Somatosensory Evoked Potentials (SSEPs)
Somatosensory Evoked Potentials (SSEPs) are electrical responses recorded from the nervous system following electrical stimulation of a peripheral nerve. For example, stimulation of the median nerve at the wrist produces electrical activity that travels along the sensory pathway on its way to the brain. This activity can be recorded with electrodes positioned along that pathway.
Measured: baseline, 96 weeks post-treatment
Number of subjects who develop a new pathologic mass at the spinal cord area of injection or anywhere along the spinal cord.
Patients will undergo Magnetic Resonance Imaging of the spine and the spinal cord with and without contrast.
Measured: approximately 96 weeks post-treatment
Change in number of red blood cells following treatment
Blood will be drawn in order to monitor for markers of systemic inflammation. The normal range of red blood cells varies slightly between laboratories but is generally between 4.2 - 5.9 million cells/cmm. This can also be referred to as the erythrocyte count and can be expressed in international units as 4.2 - 5.9 x 10^12 cells per liter.
Measured: baseline, 4 weeks post-treatment
Change in white blood cells with differential following treatment
Serological test - Automated white cell differential. A machine generated percentage of the different types of white blood cells, usually split into granulocytes, lymphocytes, monocytes, eosinophils, and basophils.
Measured: baseline, 4 weeks post-treatment
Change in number of platelets following treatment
Serological test: Platelets are not complete cells, but actually fragments of cytoplasm from a cell found in the bone marrow called a megakaryocyte. Platelets play a vital role in blood clotting. Normal range varies slightly between laboratories but is in the range of 150,000 - 400,000/ cmm (150 - 400 x 10^9/liter).
Measured: baseline, 4 weeks post-treatment
Change in Serum C-Reactive Protein (CRP)
Serological test: C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. It is one of a group of proteins called acute phase reactants that go up in response to inflammation. C-reactive protein is measured in milligrams of CRP per liter of blood (mg/L). Normal CRP levels are below 3.0 mg/dL.
Measured: baseline, 4 weeks post-treatment
Change in Erythrocyte Sedimentation Rate (ESR)
Serological test. The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. The normal range is 0-22 mm/hr for men and 0-29 mm/hr for women.
Measured: baseline, 4 weeks post-treatment
Change in Blood Urea Nitrogen (BUN)
Serological test - basic metabolic panel. A blood urea nitrogen (BUN) test measures the amount of nitrogen in the blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. A BUN test is done to see how well the kidneys are working. Results of the blood urea nitrogen test are measured in milligrams per deciliter (mg/dL).
Measured: baseline, 4 weeks post-treatment
Change in Creatinine
Serological test - basic metabolic panel. Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Almost all creatinine is filtered from the blood by the kidneys and released into the urine, so blood levels are usually a good indicator of how well the kidneys are working. Results are reported in mg/dL.
Measured: baseline, 4 weeks post-treatment
Change in Sodium
Serological test - basic metabolic panel. A sodium blood test allows the doctor to see how much sodium is in the subject's blood. It helps maintain normal blood pressure, supports the work of your nerves and muscles, and regulates your body's fluid balance. A normal sodium level is between 135 and 145 milliequivalents per liter (mEq/L) of sodium.
Measured: baseline, 4 weeks post-treatment
Change in Potassium
Serological test - basic metabolic panel. The normal potassium level in the blood is 3.5-5.0 milliEquivalents per liter (mEq/L).
Measured: baseline, 4 weeks post-treatment
Change in Chloride
Serological test - basic metabolic panel. The normal blood reference range of chloride for adults in most labs is 96 to 106 milliequivalents (mEq) per liter.
Measured: baseline, 4 weeks post-treatment
Change in Aspartate Aminotransferase (AST)
Serological test - basic metabolic panel. Inflamed or injured liver cells leak higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream, which can result in elevated liver enzymes on blood tests. The reference range for aspartate aminotransferase (AST) is as follows: Males: 6-34 IU/L, Females: 8-40 IU/L.
Measured: baseline, 4 weeks post-treatment
Change in Glucose
Serological test - basic metabolic panel. For a subject without diabetes, a fasting blood sugar on awakening should be under 100 mg/dl.
Measured: baseline, 4 weeks post-treatment
Change in Carbon Dioxide
Serological test - basic metabolic panel. The normal range for carbon dioxide is 23 to 29 mEq/L (milliequivalent units per liter of blood).
Measured: baseline, 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start5 Dec 2017
- Primary completion22 Oct 2019
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamad Bydon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamad Bydon, Mayo Clinic
- Investigators
- Mohamad Bydon, MD, Principal investigator, Mayo Clinic, Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308565
- Sponsor's protocol ID
- 17-004621
- Acronym
- CELLTOP
- Status last verified
- Aug 2022
- First submitted
- 9 Oct 2017
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bydon M, Qu W, Moinuddin FM, Hunt CL, Garlanger KL, Reeves RK, Windebank AJ, Zhao KD, Jarrah R, Trammell BC, El Sammak S, Michalopoulos GD, Katsos K, Graepel SP, Seidel-Miller KL, Beck LA, Laughlin RS, Dietz AB. Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial. Nat Commun. 2024 Apr 1;15(1):2201. doi: 10.1038/s41467-024-46259-y.
PubMed 38561341Bydon M, Dietz AB, Goncalves S, Moinuddin FM, Alvi MA, Goyal A, Yolcu Y, Hunt CL, Garlanger KL, Del Fabro AS, Reeves RK, Terzic A, Windebank AJ, Qu W. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Mayo Clin Proc. 2020 Feb;95(2):406-414. doi: 10.1016/j.mayocp.2019.10.008. Epub 2019 Nov 27.
PubMed 31785831
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03308565
- Acronym / sponsor ID
- CELLTOP / 17-004621
- Conditions
- Spinal Cord Injuries, Paralysis
- Keywords
- AIS grade A or B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mohamad BydonUniversity, hospital or other
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 12 Oct 2017 (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 study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
Detailed description
The proposed study is an open label, prospective Phase I safety and feasibility study of the intrathecal injection of autologous culture-expanded AD-MSCs in patients with severe traumatic spinal cord injury (SCI). All subjects will receive the same dosage of stem cells via intrathecal injection. Enrolled subjects will first undergo a minor surgical procedure in which a sample of the patient's adipose tissue will be harvested from a small incision in the patient's abdomen or thigh. The subject's adipose tissue will then be used to derive and culture-expand AD-MSCs for 4-6 weeks. Autologous AD-MSCs will be transplanted through intrathecal injection at the level of L4-5 under fluoroscopic guidance at a single dose of 100 million cells. Patients will be evaluated at set intervals following the injection: day 2, day 3, week 1, week 2, week 4, week 24, weeks 48, week 72 and week 96.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Biological: Autologous, Adipose derived Mesenchymal Stem CellsPatients will receive a single dose of 100 million autologous, adipose derived mesenchymal stem cells. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 years and older
- AIS grade A or B of SCI
- SCI must be traumatic, blunt/non-penetrating in nature and not degenerative
- SCI must be within two weeks and up to 1 year after the event
- Full understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, complete physical and neurologic examination and follow-up visits and assessments
Key exclusion criteria (18 listed)
- Pregnant or nursing, or planning on becoming pregnant during the study period
- AIS grade of SCI other than A or B
- History of intra-spinal infection
- History of superficial infection in the index spinal level within 6 months of study
- Evidence of current superficial infection affecting the index spinal level at the time of enrollment
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 derived Mesenchymal Stem CellsThe mesenchymal stem cells will be collected and expanded from the subjects adipose tissue. | Biological | Phase I |
Primary outcome
Incidence of acute adverse events
Time frame: up to 4 weeks post treatment
An adverse event is defined any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship to the study drug
21 secondary outcomes
Incidence of delayed adverse events
Time frame: 48 weeks post treatment
Severity of adverse events
Time frame: 4 weeks post-treatment
Relationship of adverse events to study drug
Time frame: 4 weeks post-treatment
Incidence of serious adverse events (SAE)
Time frame: 48 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time frame: baseline, 96 weeks
Change in sensory and motor function following completion of treatment as measured by motor evoked potentials (MEP)
Time frame: baseline, 96 weeks post-treatment
Change in sensory and motor function following completion of treatment as measured by Somatosensory Evoked Potentials (SSEPs)
Time frame: baseline, 96 weeks post-treatment
Number of subjects who develop a new pathologic mass at the spinal cord area of injection or anywhere along the spinal cord.
Time frame: approximately 96 weeks post-treatment
Change in number of red blood cells following treatment
Time frame: baseline, 4 weeks post-treatment
Change in white blood cells with differential following treatment
Time frame: baseline, 4 weeks post-treatment
Change in number of platelets following treatment
Time frame: baseline, 4 weeks post-treatment
Change in Serum C-Reactive Protein (CRP)
Time frame: baseline, 4 weeks post-treatment
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: baseline, 4 weeks post-treatment
Change in Blood Urea Nitrogen (BUN)
Time frame: baseline, 4 weeks post-treatment
Change in Creatinine
Time frame: baseline, 4 weeks post-treatment
Change in Sodium
Time frame: baseline, 4 weeks post-treatment
Change in Potassium
Time frame: baseline, 4 weeks post-treatment
Change in Chloride
Time frame: baseline, 4 weeks post-treatment
Change in Aspartate Aminotransferase (AST)
Time frame: baseline, 4 weeks post-treatment
Change in Glucose
Time frame: baseline, 4 weeks post-treatment
Change in Carbon Dioxide
Time frame: baseline, 4 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 38561341Bydon M, Qu W, Moinuddin FM, Hunt CL, Garlanger KL, Reeves RK, Windebank AJ, Zhao KD, Jarrah R, Trammell BC, El Sammak S, Michalopoulos GD, Katsos K, Graepel SP, Seidel-Miller KL, Beck LA, Laughlin RS, Dietz AB. Intrathecal delivery of adipose-derived mesenchymal stem cells in traumatic spinal cord injury: Phase I trial. Nat Commun. 2024 Apr 1;15(1):2201. doi: 10.1038/s41467-024-46259-y.
- Derived from this study: PubMed 31785831Bydon M, Dietz AB, Goncalves S, Moinuddin FM, Alvi MA, Goyal A, Yolcu Y, Hunt CL, Garlanger KL, Del Fabro AS, Reeves RK, Terzic A, Windebank AJ, Qu W. CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury. Mayo Clin Proc. 2020 Feb;95(2):406-414. doi: 10.1016/j.mayocp.2019.10.008. Epub 2019 Nov 27.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mohamad Bydon, MD principal investigator
Mayo Clinic, Rochester, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous, Adipose derived Mesenchymal Stem Cells in people with Spinal Cord Injuries and Paralysis, run by Mohamad Bydon at 1 site in United States.
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 8 inclusion and 18 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: finished, as of the sponsor's last update on 30 Aug 2022. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of acute adverse events (time frame: up to 4 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308565, which also lists 2 linked publications.
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 30 Aug 2022.