Traumatic Encephalopathies, ChronicEarly Phase 1C-TBINCT02959294
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
A Early Phase 1 study testing Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF in people with Traumatic Encephalopathies, Chronic and Concussion, Mild, run by Robert W. Alexander, MD, FICS at 1 site in United States.
Trial summary
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate
- What is being tested?
- Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to Mar 2024
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented history of mTBI or TBI with Correlated MRI or CT
- At least 1 month post mTBI and TBI
- Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval
- Able to provide informed consent to undergo the study
- Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent changes which followed a traumatic brain event (TBI)
- Impaired social or occupational functioning following mTBI or TBI
- History of repetitive events for mTBI and TBI
Who cannot join
- Documented history of neuro-degenerative illness, seizures, mental illness, or severe medical conditions preceding mTBI or TBI
- Malignances, Bleeding Disorders, Pregnancy or Lactation
- Tumors of Central Nervous System (CNS)
- Lack of adequate donor tissue volume as determined by the primary investigator at their discretion
- Any pre-existing medical condition which, in view of the primary investigator and patient's primary care physician, would prevent participation in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.
Read the detailed description
Concussion Syndrome (CS) and TBI are common injuries producing temporary and long-term damage to impact brain function. Symptoms are sometimes transient, sometimes long-term depending on severity and/or repetitive damage. Signs varying from recurrent headaches, mental fog, emotional changes to physical signs of loss of consciousness, amnesia to behavioral change (irritability, loss of concentration ability, etc.), cognitive impairment (slow reaction times, memory loss), and recurring sleep disturbances.
Common causes include sports injuries, automobile accidents, falls, blunt trauma to head, and explosive/blast injuries from production of acceleration injuries
Treatment often involves monitoring, physical rest, limiting cognitive activities (such as computing, video games, texting, and studying). Most often a single episode usually resolve or improve (particularly in recurring headaches) within 3-4 weeks. It is estimated that >6/1000 occurrence rate apply. Repetitive injuries seem to make the person more susceptible to additional damage, particularly with injury precedes resolution of an earlier damage. There appears also to make persons to require a lesser impact to produce the same degree of severity. It is becoming more recognized that repeated concussions increase the risks in later life for dementia, Parkinson's and severe depressions.
Most serious signs to evaluate are loss of consciousness, seizures, worsening headache, diplopia/pupil changes, loss of recognition, vomiting, focal neurological problems, and change of personality.
There is no consensus definition of concussion or TBI. Most concussions are considered in the mild TBI (mTBI) group, and are rarely demonstrate structural brain damage when in the acute to subacute state. Late brain MRI changes are difficult to clearly point to or identify the specific areas of presumed damage.
This study is intended to examine safety and efficacy of parenteral introduction of AD-cSVF in cases of CS and TBI, and categorically examine the outcomes according to the elapsed time from original concussive event. No delineation of those having recurrent damage and injuries are made within this study.
- Conditions
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe, Concussion, Brain
- Being tested
- Microcannula Harvest Adipose, Centricyte 1000, Sterile Normal Saline IV deployment AD-cSVF
- Keywords
- TBI, mTBI, Concussion, Brain, Loss Consciousness, Traumatic, Headaches
- Medical subject headings
- Brain Injuries, Traumatic, Bronchiolitis Obliterans Syndrome, Brain Concussion, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcannula Harvest AdiposeProcedure or surgery
Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
Centricyte 1000Device
Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF
Sterile Normal Saline IV deployment AD-cSVFProcedure or surgery
Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
| Study group | Role | What they receive |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Acquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits Receives: Procedure: Microcannula Harvest Adipose |
| Centricyte 1000 | Experimental | Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF Receives: Device: Centricyte 1000 |
| Sterile Normal Saline | Experimental | Re-suspension of AD-cSVF pellet in Normal Saline deployment via IV Receives: Procedure: Sterile Normal Saline IV deployment AD-cSVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Activities of Daily Living (ADL)
Measured: Outcome measures at baseline at 6 month
Cognitive Change in clinical symptoms associated with concussion-TBI
Montreal Cognitive Assessment Scale (MCAS)
Measured: Outcome measures at baseline and reviewed 1 year interval for average time 5 years
Secondary outcomes (3)
Beck's Depression Inventory (BDI)
Multiple choice self reporting measure of depression
Measured: Annual for 5 years
Adult Attention Deficit Assessment
Conner's Adult Attention Deficit Disorder Rate Scale (CAADDR)
Measured: Annual for 5 years
MRI Brain With & MRI Brain With & Without Contrast
MRI Brain to evaluate progressive changes comparing pre-treatment (0), 3 year and 5 year status
Measured: 0, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start30 Nov 2018
- Primary completionNov 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Traumatic Encephalopathies, ChronicStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert W. Alexander, MD, FICS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
- Investigators
- Robert W. Alexander, MD, Principal investigator, GARM International and GARM USAGlenn C Terry, MD, Principal investigator, GARM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959294
- Sponsor's protocol ID
- RGV GARM 5
- Acronym
- C-TBI
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Annual Summary of Case to All Collaborators
Publications
Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.
PubMed 18635021Parikh S, Koch M, Narayan RK. Traumatic brain injury. Int Anesthesiol Clin. 2007 Summer;45(3):119-35. doi: 10.1097/AIA.0b013e318078cfe7. No abstract available.
PubMed 17622833Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586.
PubMed 18627252Kumar R, Husain M, Gupta RK, Hasan KM, Haris M, Agarwal AK, Pandey CM, Narayana PA. Serial changes in the white matter diffusion tensor imaging metrics in moderate traumatic brain injury and correlation with neuro-cognitive function. J Neurotrauma. 2009 Apr;26(4):481-95. doi: 10.1089/neu.2008.0461.
PubMed 19196176Pellman EJ, Viano DC; National Football League's Committee on Mild Traumatic Brain Injury. Concussion in professional football: summary of the research conducted by the National Football League's Committee on Mild Traumatic Brain Injury. Neurosurg Focus. 2006 Oct 15;21(4):E12. doi: 10.3171/foc.2006.21.4.13.
PubMed 17112190Heegaard W, Biros M. Traumatic brain injury. Emerg Med Clin North Am. 2007 Aug;25(3):655-78, viii. doi: 10.1016/j.emc.2007.07.001.
PubMed 17826211Pearce JM. Observations on concussion. A review. Eur Neurol. 2008;59(3-4):113-9. doi: 10.1159/000111872. Epub 2007 Nov 30.
PubMed 18057896Concussion (mild traumatic brain injury) and the team physician: a consensus statement. Med Sci Sports Exerc. 2005 Nov;37(11):2012-6. doi: 10.1249/01.mss.0000186726.18341.70. No abstract available.
PubMed 16286874Hall RC, Hall RC, Chapman MJ. Definition, diagnosis, and forensic implications of postconcussional syndrome. Psychosomatics. 2005 May-Jun;46(3):195-202. doi: 10.1176/appi.psy.46.3.195.
PubMed 15883140Maroon JC, Lovell MR, Norwig J, Podell K, Powell JW, Hartl R. Cerebral concussion in athletes: evaluation and neuropsychological testing. Neurosurgery. 2000 Sep;47(3):659-69; discussion 669-72. doi: 10.1097/00006123-200009000-00027.
PubMed 10981754Randolph C. Baseline neuropsychological testing in managing sport-related concussion: does it modify risk? Curr Sports Med Rep. 2011 Jan-Feb;10(1):21-6. doi: 10.1249/JSR.0b013e318207831d.
PubMed 21228656Binder LM. Persisting symptoms after mild head injury: a review of the postconcussive syndrome. J Clin Exp Neuropsychol. 1986 Aug;8(4):323-46. doi: 10.1080/01688638608401325.
PubMed 3091631Thornton KE, Carmody DP. Efficacy of traumatic brain injury rehabilitation: interventions of QEEG-guided biofeedback, computers, strategies, and medications. Appl Psychophysiol Biofeedback. 2008 Jun;33(2):101-24. doi: 10.1007/s10484-008-9056-z. Epub 2008 Jun 13.
PubMed 18551365Alexander MP. Mild traumatic brain injury: pathophysiology, natural history, and clinical management. Neurology. 1995 Jul;45(7):1253-60. doi: 10.1212/wnl.45.7.1253. No abstract available.
PubMed 7617178De Beaumont L, Theoret H, Mongeon D, Messier J, Leclerc S, Tremblay S, Ellemberg D, Lassonde M. Brain function decline in healthy retired athletes who sustained their last sports concussion in early adulthood. Brain. 2009 Mar;132(Pt 3):695-708. doi: 10.1093/brain/awn347. Epub 2009 Jan 28.
PubMed 19176544
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Adipose-Derived Cellular Stromal Vascular Fraction (AD-cSVF) Parenterally in Post-Concussion Injuries and Traumatic Brain Injuries (TBI)
- ClinicalTrials.gov ID
- NCT02959294
- Acronym / sponsor ID
- C-TBI / RGV GARM 5
- Conditions
- Traumatic Encephalopathies, Chronic, Concussion, Mild, Concussion, Intermediate, Concussion, Severe, Concussion, Brain
- Keywords
- TBI, mTBI, Concussion, Brain, Loss Consciousness, Traumatic, Headaches
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]\]
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Robert W. Alexander, MD, FICSIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 9 Nov 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.
Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.
Detailed description
Concussion Syndrome (CS) and TBI are common injuries producing temporary and long-term damage to impact brain function. Symptoms are sometimes transient, sometimes long-term depending on severity and/or repetitive damage. Signs varying from recurrent headaches, mental fog, emotional changes to physical signs of loss of consciousness, amnesia to behavioral change (irritability, loss of concentration ability, etc.), cognitive impairment (slow reaction times, memory loss), and recurring sleep disturbances.
Common causes include sports injuries, automobile accidents, falls, blunt trauma to head, and explosive/blast injuries from production of acceleration injuries
Treatment often involves monitoring, physical rest, limiting cognitive activities (such as computing, video games, texting, and studying). Most often a single episode usually resolve or improve (particularly in recurring headaches) within 3-4 weeks. It is estimated that >6/1000 occurrence rate apply. Repetitive injuries seem to make the person more susceptible to additional damage, particularly with injury precedes resolution of an earlier damage. There appears also to make persons to require a lesser impact to produce the same degree of severity. It is becoming more recognized that repeated concussions increase the risks in later life for dementia, Parkinson's and severe depressions.
Most serious signs to evaluate are loss of consciousness, seizures, worsening headache, diplopia/pupil changes, loss of recognition, vomiting, focal neurological problems, and change of personality.
There is no consensus definition of concussion or TBI. Most concussions are considered in the mild TBI (mTBI) group, and are rarely demonstrate structural brain damage when in the acute to subacute state. Late brain MRI changes are difficult to clearly point to or identify the specific areas of presumed damage.
This study is intended to examine safety and efficacy of parenteral introduction of AD-cSVF in cases of CS and TBI, and categorically examine the outcomes according to the elapsed time from original concussive event. No delineation of those having recurrent damage and injuries are made within this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microcannula Harvest Adipose | Experimental | Procedure: Microcannula Harvest AdiposeAcquisition Adipose-Derived Tissue Stromal Vascular Fraction (AD-tSVF) via close syringe microcannula harvest from subdermal fat deposits |
| Centricyte 1000 | Experimental | Device: Centricyte 1000Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 Closed System to create AD-cSVF |
| Sterile Normal Saline | Experimental | Procedure: Sterile Normal Saline IV deployment AD-cSVFRe-suspension of AD-cSVF pellet in Normal Saline deployment via IV |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Documented history of mTBI or TBI with Correlated MRI or CT
- At least 1 month post mTBI and TBI
- Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval
- Able to provide informed consent to undergo the study
- Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent changes which followed a traumatic brain event (TBI)
Key exclusion criteria (5 listed)
- Documented history of neuro-degenerative illness, seizures, mental illness, or severe medical conditions preceding mTBI or TBI
- Malignances, Bleeding Disorders, Pregnancy or Lactation
- Tumors of Central Nervous System (CNS)
- Lack of adequate donor tissue volume as determined by the primary investigator at their discretion
- Any pre-existing medical condition which, in view of the primary investigator and patient's primary care physician, would prevent participation in study
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 |
|---|---|---|
| Microcannula Harvest AdiposeUse of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells | Procedure or surgery | Microcannula Harvest Adipose |
| Centricyte 1000Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF | Device | Centricyte 1000 |
| Sterile Normal Saline IV deployment AD-cSVFSterile Normal Saline Suspension AD-cSVF in 500 cc IV use | Procedure or surgery | Sterile Normal Saline |
Primary outcome
Number of participants with adverse events
Time frame: Outcome measures at baseline at 6 month
Activities of Daily Living (ADL)
Cognitive Change in clinical symptoms associated with concussion-TBI
Time frame: Outcome measures at baseline and reviewed 1 year interval for average time 5 years
Montreal Cognitive Assessment Scale (MCAS)
3 secondary outcomes
Beck's Depression Inventory (BDI)
Time frame: Annual for 5 years
Adult Attention Deficit Assessment
Time frame: Annual for 5 years
MRI Brain With & MRI Brain With & Without Contrast
Time frame: 0, 3 years, 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 18635021Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.
- Background: PubMed 17622833Parikh S, Koch M, Narayan RK. Traumatic brain injury. Int Anesthesiol Clin. 2007 Summer;45(3):119-35. doi: 10.1097/AIA.0b013e318078cfe7. No abstract available.
- Background: PubMed 18627252Saatman KE, Duhaime AC, Bullock R, Maas AI, Valadka A, Manley GT; Workshop Scientific Team and Advisory Panel Members. Classification of traumatic brain injury for targeted therapies. J Neurotrauma. 2008 Jul;25(7):719-38. doi: 10.1089/neu.2008.0586.
- Background: PubMed 19196176Kumar R, Husain M, Gupta RK, Hasan KM, Haris M, Agarwal AK, Pandey CM, Narayana PA. Serial changes in the white matter diffusion tensor imaging metrics in moderate traumatic brain injury and correlation with neuro-cognitive function. J Neurotrauma. 2009 Apr;26(4):481-95. doi: 10.1089/neu.2008.0461.
- Background: PubMed 17112190Pellman EJ, Viano DC; National Football League's Committee on Mild Traumatic Brain Injury. Concussion in professional football: summary of the research conducted by the National Football League's Committee on Mild Traumatic Brain Injury. Neurosurg Focus. 2006 Oct 15;21(4):E12. doi: 10.3171/foc.2006.21.4.13.
- Background: PubMed 17826211Heegaard W, Biros M. Traumatic brain injury. Emerg Med Clin North Am. 2007 Aug;25(3):655-78, viii. doi: 10.1016/j.emc.2007.07.001.
- Background: PubMed 18057896Pearce JM. Observations on concussion. A review. Eur Neurol. 2008;59(3-4):113-9. doi: 10.1159/000111872. Epub 2007 Nov 30.
- Background: PubMed 16286874Concussion (mild traumatic brain injury) and the team physician: a consensus statement. Med Sci Sports Exerc. 2005 Nov;37(11):2012-6. doi: 10.1249/01.mss.0000186726.18341.70. No abstract available.
- Background: PubMed 15883140Hall RC, Hall RC, Chapman MJ. Definition, diagnosis, and forensic implications of postconcussional syndrome. Psychosomatics. 2005 May-Jun;46(3):195-202. doi: 10.1176/appi.psy.46.3.195.
- Background: PubMed 10981754Maroon JC, Lovell MR, Norwig J, Podell K, Powell JW, Hartl R. Cerebral concussion in athletes: evaluation and neuropsychological testing. Neurosurgery. 2000 Sep;47(3):659-69; discussion 669-72. doi: 10.1097/00006123-200009000-00027.
- Background: PubMed 21228656Randolph C. Baseline neuropsychological testing in managing sport-related concussion: does it modify risk? Curr Sports Med Rep. 2011 Jan-Feb;10(1):21-6. doi: 10.1249/JSR.0b013e318207831d.
- Background: PubMed 3091631Binder LM. Persisting symptoms after mild head injury: a review of the postconcussive syndrome. J Clin Exp Neuropsychol. 1986 Aug;8(4):323-46. doi: 10.1080/01688638608401325.
- Individual participant dataSharing planned: Undecided. Annual Summary of Case to All Collaborators
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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.
Robert W. Alexander, MD principal investigator
GARM International and GARM USA
Glenn C Terry, MD principal investigator
GARM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microcannula Harvest Adipose, Centricyte 1000 and Sterile Normal Saline IV deployment AD-cSVF in people with Traumatic Encephalopathies, Chronic and Concussion, Mild, run by Robert W. Alexander, MD, FICS 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 7 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: withdrawn, as of the sponsor's last update on 16 Feb 2021. 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?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with adverse events (time frame: Outcome measures at baseline at 6 month). The study lists 2 primary outcomes in all. 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 NCT02959294, which also lists 20 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 16 Feb 2021.