Lumbosacral RadiculopathyNCT06924853
Platelet Lysate vs Saline for Lumbosacral Radiculopathy
A study testing Platelet lysate in people with Lumbosacral Radiculopathy and Lumbar Radiculopathy, run by Regenexx, LLC at 1 site in United States.
Trial summary
This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbosacral Radiculopathy, Lumbar Radiculopathy
- What is being tested?
- Platelet lysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 5 Nov 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18-65 years of age, inclusive, at time of signing informed consent
- At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
- Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit
- Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
- Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
- LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs.
Show all 9Show fewer
- Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI.
- Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
- Voluntary signature of the IRB approved Informed Consent
Who cannot join
- Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
- Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
- Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments
Show all 18Show fewer
- Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT
- Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)
- Presence of spinal cord stimulator
- Received epidural steroid injection or nerve blocks within the last 2 months
- Use of chronic opioids
- Documented history of drug abuse within the last 6 months
- Use of immunosuppressants, oral or intravenous steroids in the last 3 months
- Is pregnant
- Allergy or intolerance to study medication (e.g. lidocaine, etc.)
- Condition represents a worker's comp case and/or is involved in health-related litigation
- Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study
- Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Blind, Randomized, Controlled, Crossover Study of Autologous Platelet Lysate Versus Saline in Adults With Lumbosacral Radiculopathy
This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).
Read the detailed description
This single-center, single-blind, randomized-controlled clinical trial will enroll approximately 20 participants, randomized in a 1:1 ratio to receive either autologous PL (N=10) or saline (N=10) epidural injections for patients with lumbar radiculopathy.
Prior to enrollment, patients will undergo evaluation of medical history, back pain history, lumbar examination, radicular symptoms, medication use and review lumbar spine imaging.
Treatment will consist of lumbar transforaminal epidural at affected level/side. On the morning of the procedure, all patients will undergo a blood draw to maintain blinding of study condition. Patients in the active treatment group will receive an epidural injection of platelet lysate. Patients in the control group will receive an epidural injection of saline.
Patients will be blinded to study condition until the 3-month post-treatment follow-up. After completing the 3-month surveys, the patients will be unblinded. Patients that had been in the saline control group will be given the opportunity to cross-over into the active treatment group and re-start study timeline, completing follow-up surveys at 1, 2, 3- and 6- months.
The primary objective of this study is to compare the changes in patient-reported outcomes between the 2 groups (control versus treatment) for leg pain. Secondary objectives include comparing the change scores of other patient reported outcomes of back pain and function at 3-months, as well as continued evaluation of efficacy and durability up to 6-months in active treatment group. Change scores will be calculated by taking the difference between the 3-month scores and the baseline scores. Patients will complete subject-reported clinical questionnaires at pre-treatment, 1-month, 2-months, 3-months, and 6-months (6-m questionnaires only in the active treatment group).
- Conditions
- Lumbosacral Radiculopathy, Lumbar Radiculopathy
- Being tested
- Platelet lysate, Saline control
- Keywords
- lumbosacral radiculopathy, lumbosacral radicular pain, lumbar radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet lysateOther
The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis (Beckman Coulter DxH 500 Series). Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. Once flow is confirmed, the physician will inject 4mL of the PL, and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. A 0.22 micron filter will be used.
Saline controlOther
The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis; same as active treatment to maintain blinding. Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. (6) Once flow is confirmed, the physician will inject 4mL of sterile saline (0.9%), and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Lysate | Experimental | Lumbar transforaminal epidural of autologous platelet lysate Receives: Other: Platelet lysate |
| Saline | Placebo comparator | Lumbar transforaminal epidural of saline Receives: Other: Saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale (NPS)-Leg
Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain in regard to leg pain
Measured: 3-months
Secondary outcomes (10)
Numeric Pain Scale (NPS)-Leg
Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Measured: Baseline, 1-month, 2-month, 3-month, 6-month
Numeric Pain Scale (NPS)-Back
Changes in NPS from pre to post treatment; scale ranges from 0-10 where 0=no pain and 10=worst possible pain
Measured: Baseline, 1-month, 2-month, 3-month, 6-month
Mean modified SANE scores
Average SANE scores post-treatment; scores range from 0-100 where 0=no improvement and 100=100% improved
Measured: Baseline, 1-month, 2-month, 3-month, 6-month
Functional Rating Index (FRI)
Changes in FRI from pre to post treatment and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very severe disability
Measured: Baseline, 1-month, 2-month, 3-month, 6-month
Oswestry Disability Index (ODI)
Changes in ODI from pre to post and between group differences at 3 months; scales 0-100% where 0%=no disability and 100%=very disabled.
Measured: Baseline, 1-month, 2-month, 3-month, 6-month
Patient Global Impression of Change (PGIC)
Evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status (From "Very Much Improved" to "Very Much Worse")
Measured: 1-month, 2-month, 3-month, 6-month
Patient Global Impression of Severity (PGIS)
Evaluate the severity of your overall health status (From "None" to "Very Severe"
Measured: Baseline
Incidence rate of adverse events
Incidence of adverse events after treatment
Measured: 1-month, 2-month, 3-month, 6-month
Incidence rate of surgical/other treatment interventions
Incidence of surgical/other treatment interventions after treatment
Measured: 1-month, 2-month, 3-month, 6-month
Pain medications
Changes in medications from pre to post treatment
Measured: Baseline and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jul 2025
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are randomized either to active treatment or control group. Patients in control group can crossover to treatment group after 3-month time point.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924853
- Sponsor's protocol ID
- RGX2025-01
- Status last verified
- Feb 2026
- First submitted
- 4 Apr 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Williams C, Jerome M, Fausel C, Dodson E, Stemper I, Centeno C. Regenerative Injection Treatments Utilizing Platelet Products and Prolotherapy for Cervical Spine Pain: A Functional Spinal Unit Approach. Cureus. 2021 Oct 8;13(10):e18608. doi: 10.7759/cureus.18608. eCollection 2021 Oct.
PubMed 34659923Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
PubMed 17445735Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.
PubMed 26314234Capelli C, Domenghini M, Borleri G, Bellavita P, Poma R, Carobbio A, Mico C, Rambaldi A, Golay J, Introna M. Human platelet lysate allows expansion and clinical grade production of mesenchymal stromal cells from small samples of bone marrow aspirates or marrow filter washouts. Bone Marrow Transplant. 2007 Oct;40(8):785-91. doi: 10.1038/sj.bmt.1705798. Epub 2007 Aug 6.
PubMed 17680021Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
PubMed 29177632
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Blind, Randomized, Controlled, Crossover Study of Autologous Platelet Lysate Versus Saline in Adults With Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06924853
- Acronym / sponsor ID
- RGX2025-01
- Conditions
- Lumbosacral Radiculopathy, Lumbar Radiculopathy
- Keywords
- lumbosacral radiculopathy, lumbosacral radicular pain, lumbar radiculopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 11 Apr 2025 (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.
This is a randomized trial to evaluate and compare platelet lysate epidural injection to saline epidural injection for the treatment of lumbar radiculopathy (sciatica).
Detailed description
This single-center, single-blind, randomized-controlled clinical trial will enroll approximately 20 participants, randomized in a 1:1 ratio to receive either autologous PL (N=10) or saline (N=10) epidural injections for patients with lumbar radiculopathy.
Prior to enrollment, patients will undergo evaluation of medical history, back pain history, lumbar examination, radicular symptoms, medication use and review lumbar spine imaging.
Treatment will consist of lumbar transforaminal epidural at affected level/side. On the morning of the procedure, all patients will undergo a blood draw to maintain blinding of study condition. Patients in the active treatment group will receive an epidural injection of platelet lysate. Patients in the control group will receive an epidural injection of saline.
Patients will be blinded to study condition until the 3-month post-treatment follow-up. After completing the 3-month surveys, the patients will be unblinded. Patients that had been in the saline control group will be given the opportunity to cross-over into the active treatment group and re-start study timeline, completing follow-up surveys at 1, 2, 3- and 6- months.
The primary objective of this study is to compare the changes in patient-reported outcomes between the 2 groups (control versus treatment) for leg pain. Secondary objectives include comparing the change scores of other patient reported outcomes of back pain and function at 3-months, as well as continued evaluation of efficacy and durability up to 6-months in active treatment group. Change scores will be calculated by taking the difference between the 3-month scores and the baseline scores. Patients will complete subject-reported clinical questionnaires at pre-treatment, 1-month, 2-months, 3-months, and 6-months (6-m questionnaires only in the active treatment group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients are randomized either to active treatment or control group. Patients in control group can crossover to treatment group after 3-month time point.
| Arm | Type | Receives |
|---|---|---|
| Platelet Lysate | Experimental | Other: Platelet lysateLumbar transforaminal epidural of autologous platelet lysate |
| Saline | Placebo comparator | Other: Saline controlLumbar transforaminal epidural of saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be 18-65 years of age, inclusive, at time of signing informed consent
- At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
- Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 2 year prior to screening visit
- Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
- Presence of persistent unilateral radicular pain. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
Key exclusion criteria (18 listed)
- Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
- Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet lysateThe day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis (Beckman Coulter DxH 500 Series). Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. Once flow is confirmed, the physician will inject 4mL of the PL, and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. A 0.22 micron filter will be used. | Other | Platelet Lysate |
| Saline controlThe day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist into 8 yellow top tubes and 1 purple top tube and processed into 5cc PL of which 4cc will be used for treatment and the remaining 1cc will be frozen and used for QC. A lavender top blood tube will be collected and used for quantitative CBC analysis; same as active treatment to maintain blinding. Patient will lie on table prone with a pillow under their abdomen to flatten their L-spine, sterilely prepped and draped. Provider to put patient in conscious sedation to maintain study blinding. The physician will then use a 25-gauge needle under intermittent x-ray visualization to access the TF space. The physician will inject the TF space with x-ray contrast (0.5mL of OMNIPAQUE) to confirm epidural flow. (6) Once flow is confirmed, the physician will inject 4mL of sterile saline (0.9%), and 0.5mL of 0.5% ropivacaine into the epidural space at each level of interest. | Other | Saline |
Primary outcome
Numeric Pain Scale (NPS)-Leg
Time frame: 3-months
Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain in regard to leg pain
10 secondary outcomes
Numeric Pain Scale (NPS)-Leg
Time frame: Baseline, 1-month, 2-month, 3-month, 6-month
Numeric Pain Scale (NPS)-Back
Time frame: Baseline, 1-month, 2-month, 3-month, 6-month
Mean modified SANE scores
Time frame: Baseline, 1-month, 2-month, 3-month, 6-month
Functional Rating Index (FRI)
Time frame: Baseline, 1-month, 2-month, 3-month, 6-month
Oswestry Disability Index (ODI)
Time frame: Baseline, 1-month, 2-month, 3-month, 6-month
Patient Global Impression of Change (PGIC)
Time frame: 1-month, 2-month, 3-month, 6-month
Patient Global Impression of Severity (PGIS)
Time frame: Baseline
Incidence rate of adverse events
Time frame: 1-month, 2-month, 3-month, 6-month
Incidence rate of surgical/other treatment interventions
Time frame: 1-month, 2-month, 3-month, 6-month
Pain medications
Time frame: Baseline and 3-months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 34659923Williams C, Jerome M, Fausel C, Dodson E, Stemper I, Centeno C. Regenerative Injection Treatments Utilizing Platelet Products and Prolotherapy for Cervical Spine Pain: A Functional Spinal Unit Approach. Cureus. 2021 Oct 8;13(10):e18608. doi: 10.7759/cureus.18608. eCollection 2021 Oct.
- Background: PubMed 17445735Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
- Background: PubMed 26314234Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.
- Background: PubMed 17680021Capelli C, Domenghini M, Borleri G, Bellavita P, Poma R, Carobbio A, Mico C, Rambaldi A, Golay J, Introna M. Human platelet lysate allows expansion and clinical grade production of mesenchymal stromal cells from small samples of bone marrow aspirates or marrow filter washouts. Bone Marrow Transplant. 2007 Oct;40(8):785-91. doi: 10.1038/sj.bmt.1705798. Epub 2007 Aug 6.
- Background: PubMed 29177632Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet lysate in people with Lumbosacral Radiculopathy and Lumbar Radiculopathy, run by Regenexx, LLC 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 9 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: stopped early, as of the sponsor's last update on 25 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Slow enrollment). 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?
Numeric Pain Scale (NPS)-Leg (time frame: 3-months). 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 NCT06924853, which also lists 5 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 25 Feb 2026.