Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD (ACTIVE)
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|ClinicalTrials.gov Identifier: NCT04759105|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
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).
|Condition or disease||Intervention/treatment||Phase|
|Intervertebral Disc Degeneration Chronic Low-back Pain||Drug: Autologous BM-MSC Other: Sham Procedure||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in 2 arms of 26 patients and followed up for 12 months.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||The randomization result will be a treatment code. The treatment code of the patient will be transmitted to local pharmacy. Blinding or masking will be carried out at all stages of packaging and conditioning for shipping following the treatment allocation. Injections used for all groups will be clear and indistinguishable from each other.|
|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|
|Actual Study Start Date :||November 17, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Autologous BM-MSC injection
Drug: Autologous BM-MSC
intradiscal injection of autologous bone marrow mesenchymal stromal/stem cells
Other Name: Treated
Sham Comparator: Sham Procedure
Two sham procedures:
Other: Sham Procedure
anaesthesia, no disc injection, no placebo injection
Other Name: Sham
- 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.
- Measure pain relief of the patient [ Time Frame: Baseline, 1, 3 and 6 months ]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.
- Measure functional disability index of the patient [ Time Frame: Baseline, 1, 3 and 6 months ]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).
- Evaluate disability and quality of life evolution of the patient [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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.
- Disability and quality of life evolution [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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).
- Assess rescue painkillers medication [ Time Frame: Baseline, 1, 3, 6 and 12 months ]Rescue medication use will be recorded throughout the study duration by a diary file.
- Structural assessment [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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.
- Evaluation of cost [ Time Frame: 12 months ]
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
- Work disruption
- Incidence of Adverse Events (AE) [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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.
- Assessment of vital signs [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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).
- Evaluation of blood and urine analysis [ Time Frame: Baseline, 1, 3, 6 and 12 months ]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).
- Analysis of chemical biomarkers for tissue degeneration [ Time Frame: Baseline, 3, 6 and 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759105
|Contact: Gianluca Vadalà, MD, PhD||+39 06 firstname.lastname@example.org|
|Campus Bio-Medico University of Rome||Recruiting|
|Roma, Italy, 00128|
|Contact: Gianluca Vadalà, MD, PhD +39 06 225419187 email@example.com|
|Principal Investigator:||Gianluca Vadalà, MD, PhD||Campus Bio-Medico University of Rome|