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Recurrent Low Back PainPhase 2/3RESPINENCT03737461

Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive

A Phase 2/3 study testing Allogenic BM-MSCs Injection in people with Recurrent Low Back Pain and Degenerative Disc Disease (DDD), run by University Hospital, Montpellier at 9 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Allogenic BM-MSCs Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
9 sitesin 4 countries
Study dates
18 Feb 2019to 8 Mar 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 60 years.
  • Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy performed during at least 1 month before inclusion and pain medication with level 2 analgesics in failure or intolerant to level during at least 1 month) for at least 3 months.
  • DDD assessed by (Pfirrmann's score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann's score 1-4 maximum)
  • Low back 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

Who cannot join

  • Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization).
  • Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy).
  • 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
  • Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation > 3 mm and/or angular mobility > 15°).
Show all 17Show fewer
  • Spinal canal stenosis (Schizas score > B).
  • History of spinal infection.
  • Lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar cysts and radiculopathy
  • Previous discal puncture or previous spine surgery.
  • DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
  • Patients not eligible to the intravertebral disc surgery
  • Patients who have the risk to undergo a surgery in the next 6 months
  • 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/
  • Significant medical problems, such as uncontrolled hypertension, symptomatic heart failure; or any other clinically relevant condition or current medication that in the opinion of the investigator contra-indicates the use of any of the study or rescue medications.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

France4 sites

  • UH Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes

  • CHU Saint Antoine

    Paris, 75012

  • APHP Cochin

    Paris

Other trials in France

Spain3 sites

  • Institut de Teràpia Regenerativa Tissular

    Barcelona, 08022

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • Hospital Sagrado Corazón Valladolid

    Valladolid, 47002

Other trials in Spain

Germany1 site

  • BG Klinikum Bergmannstrost

    Halle, 06112

Other trials in Germany

Italy1 site

  • Campus Bio-Medico University of Rome

    Roma, 00128

Other trials in Italy

About this study

Official title: A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy

This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls.

This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy .

Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.

Read the detailed description

Degenerative disc disease (DDD) presents a large, unmet medical need. One of the most important public health problems, it affects 70 million Europeans, accounts for 42% of patients with chronic low back pain and costs over $100 billion each year in the European Union. DDD results in a disabling loss of mechanical function. Today, no efficient therapy is available. The disease results from degeneration of cartilage discs with loss of the collagen matrix and nucleus pulposus chondrocyte. Chronic cases often receive surgery, which may lead to biomechanical problems and accelerated degeneration of adjacent segments. Our consortium partners have developed and studied stem cell-based, regenerative therapies with encouraging results in phase 1 and 2 trials. Patients exhibited rapid and progressive improvement of functional and pain indexes by 50% within 6 months and by 65% to 78% after 1 year with no side effects. In addition, MRI T2 relaxation measurements demonstrated a significant improvement of cartilage signal. To develop the world's first effective treatment of DDD, RESPINE aims to assess, via a randomized, controlled, phase 3 clinical trial including 112 patients with DDD, the efficacy of an allogenic intervertebral mesenchymal stem cell (MSC)-based therapy. This innovative therapy aims to rapidly (within 3 months) and durably (at least 24 months) reduce pain and disability. In addition, the consortium aims to provide new knowledge on immune response \& safety associated with allogeneic BM-MSC intradiscal injection.

Being tested
Allogenic BM-MSCs Injection, Sham Procedure
Keywords
BM-MSCs, Low back pain, Lumbar degenerative disc disease (DDD)
Medical subject headings
Low Back Pain, Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic BM-MSCs InjectionDrug

    Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution

  • Sham ProcedureOther

    Also called Injection of 2 mL of 1% xylocaine

    sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment.

Study groups in NCT03737461
Study groupRoleWhat they receive
Allogenic BM-MSCs InjectionExperimentalInjection of a dose of 20.106 allogenic BM-MSCs via imaging control into the disk affected by DDD where they are expected to exert their therapeutic effects.
Receives: Drug: Allogenic BM-MSCs Injection
Sham ProcedureSham comparatoranesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment
Receives: Other: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Pain Clinical response at 12 months

    The clinical response is defined as the Pain relief measure with Visual Analogue Scale (VAS) of at least 20 mm decrease on VAS scale between baseline and month 12.

    Measured: baseline to month 12

  2. Change from Baseline Oswestry Disability Index (ODI) measure at 12 months

    at least 20% improvement of functional index ODI at month 12 compared to baseline.

    Measured: baseline to month 12

Secondary outcomes (9)

  1. Measure disability and quality of life evolution of the patient

    Assessed by Short Form-36 Health Survey (SF-36) :

    The eight sections are vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning and mental health A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: Baseline, 3,6,12 and 24 months

  2. Disability and quality of life evolution

    global assessment by the patient and the physician. 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) will be performed at 0, 3, 6, 12 and 24 months.

    Measured: baseline, 3,6,12 and 24 months

  3. Pain killers

    assessement of consumption of painkillers medication. Rescue medication use will be recorded throughout the study duration by a diary file.

    Measured: baseline, 1, 3,6,12 and 24 months

  4. Measure of the Chronic low back pain

    assessement of pain by the Visual Analogue pain Scale (VAS) during 24 months. Min value 0 - max value 100 , where 0 represents no pain and 100 represents the worst pain imaginable.

    Measured: baseline, 1, 3,6,12 and 24 months

  5. Employment and work status

    Assessement of employment and work status. For this, patients will be assign 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, 1, 3,6,12 and 24 months

  6. Structural assessment

    Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements in T2 and T1spin/echo and T1rho weighted images performed at 0, 6 12 and 24 months used as an indication of disc fluid and glycosaminoglycan (GAG) content. The "quality" of the patient's lumbar disc will be monitored non invasively using T2-weighted MRI sagittal images (Orozco et al., 2011) and, in T1spin/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 (Table by Griffin et al. Spine 2007).

    Measured: baseline, 1, 3,6,12 and 24 months

  7. Evaluation of cost

    We will compare the medical and non-medical costs between the two groups of patient. Costs will be identified for a one-year time horizon.

    For this purpose, resource use in each arm will be collected in physical units in the electronic Case Report Form (eCRF) at each clinical centre as follows:

    • Acute care medical hospitalisations related to DDD
    • Acute care surgical hospitalisations related to DDD
    • Rehabilitation hospitalisations related to DDD
    • Analgesics
    • Work disruption Resource use will be valued using production costs specific to each country or to the country having included the highest number of patients, depending on the number of patients actually included in each clinical centre.

    Measured: 24 months

  8. Immune response / Analytical control

    The assessment of the biological effect of allogeneic MSC on recipient immune response will be studied by multiparametric flow-cytometry as well as monitoring of anti HLA-I (human leukocyte antigen I) antibodies response.

    Measured: baseline, 1, and 6 months

  9. reporting of Serious Adverse Events (SAE)

    Define the safety outcomes of the clinical trial with the record of SAE

    Measured: baseline, 1, 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.

  1. First posted9 Nov 2018
  2. Study start18 Feb 2019
  3. Primary completion30 May 2022
  4. Study completion8 Mar 2026 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737461
Sponsor's protocol ID
RECHMPL17_0206
Other IDs
2017-002092-25, 2017
Acronym
RESPINE
Status last verified
Sep 2025
First submitted
19 Jun 2018
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pers YM, Soler-Rich R, Vadala G, Ferreira R, Duflos C, Picot MC, Herman F, Broussous S, Sanchez A, Noriega D, Ardura F, Alberca Zaballos M, Garcia V, Gordillo Cano V, Gonzalez-Vallinas M, Denaro V, Russo F, Guicheux J, Vilanova J, Orozco L, Meisel HJ, Alfonso M, Rannou F, Maugars Y, Berenbaum F, Barry FP, Tarte K, Louis-Plence P, Ferreira-Dos-Santos G, Garcia-Sancho J, Jorgensen C; RESPINE consortium. Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study). Ann Rheum Dis. 2024 Oct 21;83(11):1572-1583. doi: 10.1136/ard-2024-225771.

    PubMed 39393844

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Allogenic BM-MSCs Injection in people with Recurrent Low Back Pain and Degenerative Disc Disease (DDD), run by University Hospital, Montpellier at 9 sites in 4 countries.

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 6 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France, Spain, Germany, 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Change from Baseline Pain Clinical response at 12 months (time frame: baseline to month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03737461, which also lists 1 linked publication.

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 30 Sep 2025.

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