Intervertebral Disc DegenerationPhase 2ACTIVENCT04759105
Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD
A Phase 2 study testing Autologous BM-MSC in people with Intervertebral Disc Degeneration and Chronic Low-back Pain, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with sham treated controls. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Degeneration, Chronic Low-back Pain
- What is being tested?
- Autologous BM-MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2019to 27 Nov 2023
- Phase
- Phase 2
- 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
- Workers (it means subject has worked at least 2 months, even if not continuously, in the last 6 months)
- Age between 18 and 65 years.
- Signed informed consent.
- Symptomatic chronic LBP due to moderate/severe IDD [modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)] at max. 4 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes AINS, paracetamol, opioids and myorelaxant.
- Annulus fibrosus intact, demonstrated by MRI.
- Pain baseline > 40 mm on VAS (0- 100).
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- NSAID washout of at least 2 days before screening.
- Painkillers washout of at least 24 hours before screening.
- For females of childbearing potential, a negative pregnancy test must be documented at Screening.
- Men and women should use effective contraception during treatment and for at least 12 months after BM-MSC discontinuation. The complete list of contraceptive methods is described in the patient information sheet and in the paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
Who cannot join
- Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months)
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondilolisthesis).
- Spinal segmental instability assessed by dynamic X-Ray.
- Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI).
- Prior to the screening visit, has received:
- Oral corticosteroid therapy within the previous 3 months, OR
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- Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months
- Presence of a 5th level with symptomatic IDD (modified Pfirrmann score 3-5, Griffith score 4-8) in the lumbar spine.
- Spinal canal stenosis (Schizas score > B).
- History of spinal infection.
- Lumbar disc herniation and sciatica.
- Endplate abnormality such as Schmorl's Nodes.
- Previous discal puncture or previous spine surgery.
- IDD with Modic III changes on MRI images.
- Patients not eligible to the intravertebral disc surgery.
- Patients who have the risk to undergo a surgery in the next 6 months.
- Patients with local infusion device/devices for corticosteroids.
- Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
- Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception will be maintained during treatment and until the end of relevant systemic exposure. Additional pregnancy testing will be performed at the end of relevant systemic exposure. The patients will be required to use contraception from initial treatment administration until 24 months after the last dose of study drug.
- In each case of delayed menstrual period (over 1 month between menstruations), confirmation of absence of pregnancy is strongly recommended. The complete list of contraceptive methods is described in the patient information sheet.
- Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.
- Contraindication to MRI assessed by the investigator.
- Intolerance or allergy to local anaesthesia.
- Any history of Cancer or immunodeficiency disease.
- Previous transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Mesenchymal Stem/Stromal Cells for the Treatment of Workers Affected by Chronic Low Back Pain Due to Multilevel InterVErtebral Disc Degeneration: a Phase IIB Randomized Clinical Trial
ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with sham treated controls.
This trial will evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic low back pain (LBP) unresponsive to conventional therapy.
The efficacy will be evaluated 12 months after the treatment in terms of pain relief (VAS, Visual Analog Scale), functionality (ODI, Oswestry Disability Index), quality of life (SF36, Short Form - 36) and work ability index (WAI).
Read the detailed description
Low back pain (LBP) is the main cause of disability in the world, affecting all occupational sectors with different incidence rates. It is estimated that 60 percent of all workers suffer from LBP during their careers, 10 percent of which become chronic (The Lancet. September 2017). Intervertebral disc degeneration (IDD) is widely recognized as a major contributor to LBP, responsible for at least 40 percent of cases. A key characteristic of IDD is loss of matrix integrity and biomechanical functional failure. Today, no therapy can restore intervertebral disc (IVD) function or provide long-term relief from symptomatic IDD. Current therapies are aimed at pain reduction. When these treatments fail, several types of surgery are performed but they are often related to side effects, disturbance of motion and other biomechanical consequences. New strategies concentrate on treating IDD at an early stage. Encouraging results from phase 1 and 2 clinical trials suggest that cell-based regenerative therapies may provide the world first effective therapy for LBP. LBP patients treated with bone marrow mesenchymal stromal/stem cells (BM-MSC) showed rapid and progressive improvement of functional indexes of 65 percent to 78 percent over 1 year after intradiscal administration without side effect. ACTIVE is an ambitious randomized clinical trial aimed at developing a treatment for IDD based on intradiscal injection of autologous BM-MSC to improve the quality of life of workers and the disability of patients with LBP. ACTIVE main aim is to generate efficacy and safety profiles of single injections of 15 million cells/mL of autologous BM-MSC for each disc affected by IDD (up to 4 discs) versus sham procedure. The regenerative potential of BM-MSC treatment will be assessed by Magnetic Resonance Imaging (MRI) technologies on quarterly basis up to 12 months.
- Being tested
- Autologous BM-MSC, Sham Procedure
- Keywords
- Low back pain, Spine, Intervertebral disc degeneration, Mesenchymal stem cells, Bone marrow
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BM-MSCDrug
Also called Treated
intradiscal injection of autologous bone marrow mesenchymal stromal/stem cells
Sham ProcedureOther
Also called Sham
anaesthesia, no disc injection, no placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Autologous BM-MSC injection | Experimental | Two interventions:
* Bone marrow harvesting from the posterior superior iliac crest region
* Single injections of a dose of 15 million of autologous BM-MSC each disc affected by IDD (up to 4 discs) via imaging control Receives: Drug: Autologous BM-MSC |
| Sham Procedure | Sham comparator | Two sham procedures:
* Simulated bone marrow harvesting without insertion into the posterior iliac crest region
* Simulated injection under only local anaesthesia without disc injection, without placebo injection. Receives: Other: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain clinical relief
Pain clinical reduction of at least 40 percent on Visual Analogic Scale (VAS) between baseline and month 12. VAS pain scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.
Measured: Baseline to month 12
Functional disability index improvement
Functional disability reduction of 40 percent on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 12 compared with baseline. ODI scale ranges from 0 to 50 and allows evaluation of disability (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms).
Measured: Baseline to month 12
Work ability improvement
Improvement of 10 percent on Work Ability Index (WAI) at month 12 compared to baseline. The WAI is composed of 7 items and is a validated instrument that assesses the individual work ability of an employee. The total WAI score ranges from 7 to 49 and is calculated by summing up the scores of the 7 items.
Measured: Baseline to month 12
Secondary outcomes (11)
Measure pain relief of the patient
Assessed by Visual Analogic Scale (VAS). VAS pain scale ranges from 0 to 100: where 0 represents no pain and 100 represents the worst pain imaginable.
Measured: Baseline, 1, 3 and 6 months
Measure functional disability index of the patient
Assessed by ODI (Oswestry Low Back Pain Disability Questionnaire) scale which ranges from 0 to 50 (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms).
Measured: Baseline, 1, 3 and 6 months
Evaluate disability and quality of life evolution of the patient
Assessed by Short Form-36 Health Survey (SF-36) scores which consist of eight 0-100 scaled scores (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning and mental health) where a lower score corresponds to more disability and a higher score corresponds to less disability.
Measured: Baseline, 1, 3, 6 and 12 months
Disability and quality of life evolution
Assessed by the patient and the physician on: pain intensity in the lumbar spine (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme); patient's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor); physician's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor).
Measured: Baseline, 1, 3, 6 and 12 months
Assess rescue painkillers medication
Rescue medication use will be recorded throughout the study duration by a diary file.
Measured: Baseline, 1, 3, 6 and 12 months
Structural assessment
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements with T2 mapping protocol used as an indication of disc fluid and glycosaminoglycans (GAG) content. In addition MRI spectroscopy will provide an assessment of the chemical changes associated with disc degeneration. The "quality" of the patient's lumbar disc will be monitored non invasively using T2 weighted MRI sagittal images and T1spin/echo MRI at the same time points. Lumbar disc grading will be performed in the sagittal T2 weighted images by two experienced physicians independently, who will review each intervertebral disc (from L1-2 to L5-S1) by the modified Pfirrmann criteria.
Measured: Baseline, 1, 3, 6 and 12 months
Evaluation of cost
Comparison of medical and non-medical costs between the two groups of patients. Resource used in each arm will be collected in physical units in the eCRF at the clinical centre as follows:
- Acute care medical hospitalisations related to IDD
- Acute care surgical hospitalisations related to IDD
- Rehabilitation hospitalisations related to IDD
- Analgesics
- Work disruption
Measured: 12 months
Incidence of Adverse Events (AE)
Report of Adverse Events (AE). If the study patients do not spontaneously report any AE occurrence since their last visit, they will be interviewed by the investigator filling a study-specific AE checklist for recording of symptoms and complaints.
Measured: Baseline, 1, 3, 6 and 12 months
Assessment of vital signs
During each visit to the study centre, patients will undergo a physical examination with recording of vital signs (temperature, blood pressure, heart rate, height and weight).
Measured: Baseline, 1, 3, 6 and 12 months
Evaluation of blood and urine analysis
During each visit to the study centre, patients will undergo blood sampling for assessment of routine lab tests (Haematology and Biochemistry) and urine analysis (dipstick).
Measured: Baseline, 1, 3, 6 and 12 months
Analysis of chemical biomarkers for tissue degeneration
Assessment of chemical biomarkers for tissue degeneration through MRI spectroscopy. MRI spectroscopy will be used to provide an assessment of the chemical changes associated with disc degeneration (Zuo et al. 2009).
Measured: Baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start3 Nov 2019
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in 2 arms of 26 patients and followed up for 12 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Center for Outcomes Research and Clinical Epidemiology, Italy
- Responsible party
- Principal investigator, Gianluca Vadalà, Campus Bio-Medico University
- Investigators
- Gianluca Vadalà, MD, PhD, Principal investigator, Campus Bio-Medico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759105
- Sponsor's protocol ID
- ACTIVE trial_(BRIC2018-ID03)
- Other IDs
- 2019-004476-19, 2019
- Acronym
- ACTIVE
- Status last verified
- Nov 2023
- First submitted
- 29 Jan 2021
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem/Stromal Cells for the Treatment of Workers Affected by Chronic Low Back Pain Due to Multilevel InterVErtebral Disc Degeneration: a Phase IIB Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04759105
- Acronym / sponsor ID
- ACTIVE / ACTIVE trial_(BRIC2018-ID03)
- Keywords
- Low back pain, Spine, Intervertebral disc degeneration, Mesenchymal stem cells, Bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Center for Outcomes Research and Clinical Epidemiology, Italy
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 18 Feb 2021 (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.
ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with sham treated controls.
This trial will evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic low back pain (LBP) unresponsive to conventional therapy.
The efficacy will be evaluated 12 months after the treatment in terms of pain relief (VAS, Visual Analog Scale), functionality (ODI, Oswestry Disability Index), quality of life (SF36, Short Form - 36) and work ability index (WAI).
Detailed description
Low back pain (LBP) is the main cause of disability in the world, affecting all occupational sectors with different incidence rates. It is estimated that 60 percent of all workers suffer from LBP during their careers, 10 percent of which become chronic (The Lancet. September 2017). Intervertebral disc degeneration (IDD) is widely recognized as a major contributor to LBP, responsible for at least 40 percent of cases. A key characteristic of IDD is loss of matrix integrity and biomechanical functional failure. Today, no therapy can restore intervertebral disc (IVD) function or provide long-term relief from symptomatic IDD. Current therapies are aimed at pain reduction. When these treatments fail, several types of surgery are performed but they are often related to side effects, disturbance of motion and other biomechanical consequences. New strategies concentrate on treating IDD at an early stage. Encouraging results from phase 1 and 2 clinical trials suggest that cell-based regenerative therapies may provide the world first effective therapy for LBP. LBP patients treated with bone marrow mesenchymal stromal/stem cells (BM-MSC) showed rapid and progressive improvement of functional indexes of 65 percent to 78 percent over 1 year after intradiscal administration without side effect. ACTIVE is an ambitious randomized clinical trial aimed at developing a treatment for IDD based on intradiscal injection of autologous BM-MSC to improve the quality of life of workers and the disability of patients with LBP. ACTIVE main aim is to generate efficacy and safety profiles of single injections of 15 million cells/mL of autologous BM-MSC for each disc affected by IDD (up to 4 discs) versus sham procedure. The regenerative potential of BM-MSC treatment will be assessed by Magnetic Resonance Imaging (MRI) technologies on quarterly basis up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized in 2 arms of 26 patients and followed up for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Autologous BM-MSC injection | Experimental | Drug: Autologous BM-MSCTwo interventions: * Bone marrow harvesting from the posterior superior iliac crest region * Single injections of a dose of 15 million of autologous BM-MSC each disc affected by IDD (up to 4 discs) via imaging control |
| Sham Procedure | Sham comparator | Other: Sham ProcedureTwo sham procedures: * Simulated bone marrow harvesting without insertion into the posterior iliac crest region * Simulated injection under only local anaesthesia without disc injection, without placebo injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Workers (it means subject has worked at least 2 months, even if not continuously, in the last 6 months)
- Age between 18 and 65 years.
- Signed informed consent.
- Symptomatic chronic LBP due to moderate/severe IDD [modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)] at max. 4 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes AINS, paracetamol, opioids and myorelaxant.
- Annulus fibrosus intact, demonstrated by MRI.
Key exclusion criteria (27 listed)
- Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months)
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondilolisthesis).
- Spinal segmental instability assessed by dynamic X-Ray.
- Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI).
- Prior to the screening visit, has received:
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 BM-MSCAlso: Treatedintradiscal injection of autologous bone marrow mesenchymal stromal/stem cells | Drug | Autologous BM-MSC injection |
| Sham ProcedureAlso: Shamanaesthesia, no disc injection, no placebo injection | Other | Sham Procedure |
Primary outcome
Pain clinical relief
Time frame: Baseline to month 12
Pain clinical reduction of at least 40 percent on Visual Analogic Scale (VAS) between baseline and month 12. VAS pain scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.
Functional disability index improvement
Time frame: Baseline to month 12
Functional disability reduction of 40 percent on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 12 compared with baseline. ODI scale ranges from 0 to 50 and allows evaluation of disability (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms).
Work ability improvement
Time frame: Baseline to month 12
Improvement of 10 percent on Work Ability Index (WAI) at month 12 compared to baseline. The WAI is composed of 7 items and is a validated instrument that assesses the individual work ability of an employee. The total WAI score ranges from 7 to 49 and is calculated by summing up the scores of the 7 items.
11 secondary outcomes
Measure pain relief of the patient
Time frame: Baseline, 1, 3 and 6 months
Measure functional disability index of the patient
Time frame: Baseline, 1, 3 and 6 months
Evaluate disability and quality of life evolution of the patient
Time frame: Baseline, 1, 3, 6 and 12 months
Disability and quality of life evolution
Time frame: Baseline, 1, 3, 6 and 12 months
Assess rescue painkillers medication
Time frame: Baseline, 1, 3, 6 and 12 months
Structural assessment
Time frame: Baseline, 1, 3, 6 and 12 months
Evaluation of cost
Time frame: 12 months
Incidence of Adverse Events (AE)
Time frame: Baseline, 1, 3, 6 and 12 months
Assessment of vital signs
Time frame: Baseline, 1, 3, 6 and 12 months
Evaluation of blood and urine analysis
Time frame: Baseline, 1, 3, 6 and 12 months
Analysis of chemical biomarkers for tissue degeneration
Time frame: Baseline, 3, 6 and 12 months
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 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Gianluca Vadalà, MD, PhD principal investigator
Campus Bio-Medico University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous BM-MSC in people with Intervertebral Disc Degeneration and Chronic Low-back Pain, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
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 10 inclusion and 27 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 25 May 2025. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain clinical relief (time frame: Baseline to month 12). The study lists 3 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 25 May 2025.