Intervertebral Disc DegenerationPhase 2DREAMNCT05066334
Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar 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
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 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
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2021to 31 Oct 2025
- 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
- Signed informed consent.
- Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant.
- Annulus fibrosus intact, demonstrated by MRI.
- Pain baseline > 40 mm on VAS (0- 100).
- 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 24 months after BM-MSC discontinuation. 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
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).
- 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
- Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months
Show all 26Show fewer
- Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) 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 II and 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 m^2) 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 amino transferase [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 × 10^9/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 one month between menstruations) confirmation of absence of pregnancy is strongly recommended.
- 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.
Italy1 site, 1 recruiting
- Recruiting
Campus Bio-Medico University of Rome
Roma, Italy, 00128
About this study
Official title: Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem/Stromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy.
Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
Read the detailed description
Low back pain (LBP) is the global leading cause of disability, and furthermore rates sixth in terms of overall disease burden, in both developed and developing countries. LPB is a condition of all ages, from children to elderly, affecting 60-70 percent of the global population during life, and ~700 million people each year. LBP prevalence increases with age, and with populations ageing worldwide, the societal and economic burden associated with LBP will increase substantially over coming years.
Current LBP therapies are aimed at pain reduction, and do not provide restorative treatment. Such conservative strategies (e.g. painkillers and musculoskeletal rearrangement by manual and physiotherapy) rarely address the actual cause of LBP.
In a healthy spine, intervertebral discs (IVDs) separate the vertebrae to provide complex spinal flexibility while supporting large spinal loads. Intervertebral disc degeneration (IDD) is widely recognized as a major contributor to LBP, responsible for at least 40 percent of LBP cases. A key characteristic of IVD degeneration is loss of matrix integrity, thereby causing biomechanical functional failure.
Today, no therapy can restore IVD function or provide long-term relief from symptomatic IDD. New treatment strategies concentrate on treating IDD at an early stage. Stem cell research offers exciting possibilities, and advanced cell-based therapies are considered highly promising strategies in treating IVD degeneration and LBP. Encouraging results suggest that cell-based, regenerative therapies may provide the world first effective therapy for this common and debilitating disease.
The objective of DREAM is to generate efficacy and tolerability profiles of a single injection of 15 million of cells/ml of autologous BM-MSC for each disc affected by IDD (up to 3 discs) versus sham procedure. The potential of BM-MSC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by Magnetic Resonance Imaging (MRI) after 6 months, 1 and 2 years.
- Being tested
- Autologous BM-MSC, Sham
- 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 cells
ShamProcedure or surgery
Also called Untreated
local anaesthesia, no disc injection, no placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Two procedures:
1. Bone marrow harvesting from the posterior superior iliac crest region
2. Single injections of a dose of 15 million of autologous BM-MSC for each disc affected by IDD (up to 3 discs) via imaging control Receives: Drug: Autologous BM-MSC |
| Sham Procedure | Sham comparator | Two sham procedures:
1. Simulated bone marrow harvesting without insertion into the posterior iliac crest region
2. Simulated injection under only local anaesthesia without disc injection and without placebo injection. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change
Changes in pain will be evaluated on Visual Analogic Scale (VAS) between baseline and month 24. VAS scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.
Measured: From Baseline to Month 24
Functional disability index evaluation
Functional disability changes will be assessed on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 24 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: From Baseline to Month 24
Secondary outcomes (15)
Disability evolution
Disability evolution includes Short Form-36 Health Survey (SF-36) scores. SF-36 scores 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, 3, 6, 12 and 24 months
Quality of life evolution
Quality of life evolution includes global assessment by the patient and the physician.
The global assessment by the patient and the physician involves evaluation of: - Overall 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, 3, 6, 12 and 24 months
Drug consumption of rescue painkillers medication
The decrease/increase in the use of rescue medication will be recorded throughout the study duration by a diary file. A reduction in dose or frequency of administration of painkillers is an indirect marker of the benefits of MSC therapy.
Measured: Baseline, 3, 6, 12 and 24 months
Measurement of pain
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. In brief, the patients will fill VAS tests indicating the amount of pain experienced at rest and in motion.
Measured: Baseline, 3, 6, 12 and 24 months
Employment and work status assessment
For this the investigators will assign each of the patients to one of 4 categories designated as "employable" which included those who were unemployed due to pain, employed but on sick leave, laid off, or working. The other categories include retired, disabled, and elderly at least 60 years of age, eligible for social security.
Measured: Baseline and 24 months
Structural assessment
Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements in T2 and T1 spin/echo and T1 rho weighted images used as an indication of disc fluid and glycosaminoglycans (GAG) content. The "quality" of the patient's lumbar disc/discs will be monitored non invasively using T2 weighted MRI sagittal images and, in T1 spin/echo MRI. Lumbar disc grading will be performed in the sagittal T2 weighted images by two physicians independently who were experienced in MRI of the spine. They will review each intervertebral disc from L1-2 to L5-S1 by the modified Pfirrmann criteria. The modified Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade 1 to 8 for disc degeneration.
Measured: Baseline, 6, 12 and 24 months
Evaluation of costs
The investigators will compare the medical and non-medical costs between the two groups of patient. For this purpose, resource use in each arm will be collected in physical units in the eCRF (electronic case report form) 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 and 24 months
Body Mass Index evaluation
Evaluation of changes in Body Mass Index (BMI) through the measurement of weight (kg) and height (m) of each subject enrolled in the study.
Measured: Baseline, 3, 6, 12 and 24 months
Haematological evaluation: safety parameter
The investigators will assess the percentage of patients who will develop haematological disorders. For this reason, participants will undergo blood sampling for routine laboratory testing to determine haematological parameters (haematocrit, haemoglobin, RBC, WBC) to monitor the physiological status of the patient.
Measured: Baseline, 3, 6, 12 and 24 months
Coagulation status: safety parameter
The investigators will assess the incidence of disorders related to coagulation. For this reason, participants will undergo blood sampling for routine laboratory testing to determine coagulation parameters (INR, PTT) to monitor the coagulation status and hemostasis risks of each subject.
Measured: Baseline, 3, 6, 12 and 24 months
Metabolic functions: safety parameter
The investigators will evaluate the incidence of metabolic alteration in patients recruited. For this reason, participants will undergo blood sampling for routine laboratory testing to determine biochemical parameters (Electrolytes, Creatinine, ALT, AST, AP, Bilirubin) to monitor the metabolic function of liver and kidney.
Measured: Baseline, 3, 6, 12 and 24 months
Inflammation: safety parameter
Blood sampling will be used to determine the concentration of C-Reactive Protein (CRP). Participants will undergo blood sampling for routine laboratory testing to monitor inflammatory response in each subject.
Measured: Baseline, 3, 6, 12 and 24 months
Urinalysis
Participants will undergo to urinalysis which consists in routine urine tests for the semiquantitative assessment of urinary characteristics to monitor the physiological status of the subjects.
Measured: Baseline, 3, 6, 12 and 24 months
Spine examination
Participants will undergo to spine examination for the identification of relevant clinical signs. The clinicians will evaluate: abnormalities in gait (pattern of walking); spinal range of motion (eg, bend forward); posture and spinal alignment (such as scoliosis or kyphosis).
Measured: Baseline, 3, 6, 12 and 24 months
Specific Adverse Events Evaluation
Participants will be interviewed by the investigator to fill a study-specific Adverse Events checklist for recording of symptoms and complaints.
Measured: Baseline, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start22 Mar 2021
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
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 24 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (estimated)
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
- Sponsor
- Investigators
- Gianluca Vadalà, MD, PhD, Principal investigator, Campus Bio-Medico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066334
- Sponsor's protocol ID
- DREAM (GR - 2018-12367168)
- Other IDs
- 2019-002749-40, 2019
- Acronym
- DREAM
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 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
- Intervertebral Disc Regeneration Mediated by Autologous Mesenchymal Stem/Stromal Cells Intradiscal Injection: a Phase IIB Randomized Clinical Trial - DREAM Trial
- ClinicalTrials.gov ID
- NCT05066334
- Acronym / sponsor ID
- DREAM / DREAM (GR - 2018-12367168)
- Keywords
- Low Back Pain, Spine, Intervertebral Disc Degeneration, Mesenchymal Stem Cells, Bone Marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- 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
- 22 Mar 2021 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 4 Oct 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.
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy.
Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
Detailed description
Low back pain (LBP) is the global leading cause of disability, and furthermore rates sixth in terms of overall disease burden, in both developed and developing countries. LPB is a condition of all ages, from children to elderly, affecting 60-70 percent of the global population during life, and ~700 million people each year. LBP prevalence increases with age, and with populations ageing worldwide, the societal and economic burden associated with LBP will increase substantially over coming years.
Current LBP therapies are aimed at pain reduction, and do not provide restorative treatment. Such conservative strategies (e.g. painkillers and musculoskeletal rearrangement by manual and physiotherapy) rarely address the actual cause of LBP.
In a healthy spine, intervertebral discs (IVDs) separate the vertebrae to provide complex spinal flexibility while supporting large spinal loads. Intervertebral disc degeneration (IDD) is widely recognized as a major contributor to LBP, responsible for at least 40 percent of LBP cases. A key characteristic of IVD degeneration is loss of matrix integrity, thereby causing biomechanical functional failure.
Today, no therapy can restore IVD function or provide long-term relief from symptomatic IDD. New treatment strategies concentrate on treating IDD at an early stage. Stem cell research offers exciting possibilities, and advanced cell-based therapies are considered highly promising strategies in treating IVD degeneration and LBP. Encouraging results suggest that cell-based, regenerative therapies may provide the world first effective therapy for this common and debilitating disease.
The objective of DREAM is to generate efficacy and tolerability profiles of a single injection of 15 million of cells/ml of autologous BM-MSC for each disc affected by IDD (up to 3 discs) versus sham procedure. The potential of BM-MSC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by Magnetic Resonance Imaging (MRI) after 6 months, 1 and 2 years.
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 24 months.
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: Autologous BM-MSCTwo procedures: 1. Bone marrow harvesting from the posterior superior iliac crest region 2. Single injections of a dose of 15 million of autologous BM-MSC for each disc affected by IDD (up to 3 discs) via imaging control |
| Sham Procedure | Sham comparator | Procedure: ShamTwo sham procedures: 1. Simulated bone marrow harvesting without insertion into the posterior iliac crest region 2. Simulated injection under only local anaesthesia without disc injection and 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 (8 listed)
- Signed informed consent.
- Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), paracetamol, opioids and myorelaxant.
- Annulus fibrosus intact, demonstrated by MRI.
- Pain baseline > 40 mm on VAS (0- 100).
- NSAID washout of at least 2 days before screening.
Key exclusion criteria (26 listed)
- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).
- 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
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 cells | Drug | Active Arm |
| ShamAlso: Untreatedlocal anaesthesia, no disc injection, no placebo injection | Procedure or surgery | Sham Procedure |
Primary outcome
Pain Change
Time frame: From Baseline to Month 24
Changes in pain will be evaluated on Visual Analogic Scale (VAS) between baseline and month 24. VAS scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.
Functional disability index evaluation
Time frame: From Baseline to Month 24
Functional disability changes will be assessed on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 24 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).
15 secondary outcomes
Disability evolution
Time frame: Baseline, 3, 6, 12 and 24 months
Quality of life evolution
Time frame: Baseline, 3, 6, 12 and 24 months
Drug consumption of rescue painkillers medication
Time frame: Baseline, 3, 6, 12 and 24 months
Measurement of pain
Time frame: Baseline, 3, 6, 12 and 24 months
Employment and work status assessment
Time frame: Baseline and 24 months
Structural assessment
Time frame: Baseline, 6, 12 and 24 months
Evaluation of costs
Time frame: 12 and 24 months
Body Mass Index evaluation
Time frame: Baseline, 3, 6, 12 and 24 months
Haematological evaluation: safety parameter
Time frame: Baseline, 3, 6, 12 and 24 months
Coagulation status: safety parameter
Time frame: Baseline, 3, 6, 12 and 24 months
Metabolic functions: safety parameter
Time frame: Baseline, 3, 6, 12 and 24 months
Inflammation: safety parameter
Time frame: Baseline, 3, 6, 12 and 24 months
Urinalysis
Time frame: Baseline, 3, 6, 12 and 24 months
Spine examination
Time frame: Baseline, 3, 6, 12 and 24 months
Specific Adverse Events Evaluation
Time frame: Baseline, 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
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 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Vadalà, MD, PhD (+39 06 22541918, g.vadala@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Change (time frame: From Baseline to Month 24). 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?
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.