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Asset Brief

Remestemcel-L

MSB·Mesoblast·Chronic low back pain (discogenic origin)·Phase 3·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Chronic low back pain is a persistent pain condition lasting more than three months that originates in the lumbar spine. A subset of cases is attributed to degeneration of the intervertebral disc, the cushioning structure between spinal vertebrae, which can trigger an inflammatory response and ongoing pain. It is one of the leading causes of disability globally (per Global Burden of Disease Study data). Standard treatments include physiotherapy, analgesic medications, and in refractory cases, spinal surgery.
What the asset is trying to do: Remestemcel-L is an allogeneic (donor-derived) mesenchymal stem cell (MSC) product administered as an off-the-shelf intravenous or intradiscal infusion. MSCs are not thought to replace or permanently engraft into damaged tissue; instead, they are believed to act transiently by releasing anti-inflammatory and immunomodulatory signalling molecules at the site of injury (per Mesoblast mechanism description on file). This approach differs from pain drugs that block specific receptors, and from surgical approaches that physically alter spinal structures. Note that remestemcel-L is a distinct product from Mesoblast's rexlemestrocel-L (Revascor), which is used in cardiovascular and musculoskeletal programmes (per Mesoblast product descriptions).
Efficacy benchmarks in this setting: In the chronic low back pain setting, no MSC-based therapy is currently approved by the FDA or EMA, so no approved-product benchmark exists for this exact drug class and indication. For context on the broader pain/discogenic setting, intradiscal biologic and cell therapy trials have reported varying outcomes; however, no specific cited response-rate figures from a comparator product in this exact setting were available in the input data and are therefore omitted here. It should be noted that any efficacy figures reported from early-phase or single-arm cohorts of remestemcel-L in this indication are not statistically comparable to results from randomised, controlled trials in an approved therapy.
Commercial context: No MSC-based therapy is approved for chronic low back pain in any major market as of the data provided. Mesoblast's remestemcel-L (marketed as Ryoncil) received FDA approval in December 2024 for paediatric steroid-refractory acute graft-versus-host disease (GvHD), representing the first FDA-approved MSC product (per Mesoblast ASX announcement and FDA approval records). Ryoncil net revenue for the quarter ending March 2026 was reported at US$30.3 million (per Mesoblast ASX quarterly activities report, 2026-04-07). The chronic low back pain programme is a separate indication from the approved GvHD use; no disclosed partnership, licensing deal value, or manufacturing arrangement specific to the back-pain asset was available in the input data.

Trial Design

Design summary

Phase: Phase 3
Design type: [ TODO: fill in ] No trial registry record for the chronic low back pain Phase 3 trial was identified in the data provided.
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: [ TODO: fill in ]
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ] Primary completion date is not available from the trial data provided.

Asset Track Record

Did MSB deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

20 July 2026regulatory decisionN/A N/A — Mesoblast CEO Makes Investment to Increase Share Ownershiphitsrc
14 July 2026data readoutPivotal Phase 3 Trial in CLBP Achieves 300 Treated Patientshit · positivesrc ASX ↗
30 June 2026regulatory decisionrexlemestrocel-L FDA — Receives FDA BLA Filing Number and Requests Modular Reviewhit · positivesrc ASX ↗
30 June 2026regulatory decisionRemestemcel-L US BLA resubmission pathwayoverdueASX ↗
24 June 2026regulatory decisionRyoncil (remestemcel-L-rknd) FDA — Mesoblast Draws US$50M from Five-Year Non-Dilutive Facilityhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infhitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Shitsrc
13 Apr 2026data readoutResults posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyahitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for Remestemcel-L and peers

Remestemcel-L's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for Remestemcel-L. Showing past 6 months and next 12 months · 4 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026

Trial design comparison

How Remestemcel-L reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Remestemcel-L	Mesoblast	Mesenchymal Stem Cell	Phase 3[ TODO: fill in ]	[ TODO: fill in ] No trial registry record for the chronic low back pain Phase 3 trial was identified in the data provided.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low

OtherASX peers ›

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for Remestemcel-L yet. Broker coverage of Mesoblast is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did MSB deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

20 July 2026regulatory decisionN/A N/A — Mesoblast CEO Makes Investment to Increase Share Ownershiphitsrc
14 July 2026data readoutPivotal Phase 3 Trial in CLBP Achieves 300 Treated Patientshit · positivesrc ASX ↗
30 June 2026regulatory decisionrexlemestrocel-L FDA — Receives FDA BLA Filing Number and Requests Modular Reviewhit · positivesrc ASX ↗
30 June 2026regulatory decisionRemestemcel-L US BLA resubmission pathwayoverdueASX ↗
24 June 2026regulatory decisionRyoncil (remestemcel-L-rknd) FDA — Mesoblast Draws US$50M from Five-Year Non-Dilutive Facilityhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infhitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Shitsrc
13 Apr 2026data readoutResults posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyahitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for Remestemcel-L and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
ConferenceESMO Congress 2026

Trial design comparison

How Remestemcel-L reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Remestemcel-L	Mesoblast	Mesenchymal Stem Cell	Phase 3[ TODO: fill in ]	[ TODO: fill in ] No trial registry record for the chronic low back pain Phase 3 trial was identified in the data provided.	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low

OtherASX peers ›

Remestemcel-Ln = 0

Mesoblast·Mesenchymal Stem Cell·Phase 3·[ TODO: fill in ]

Design: [ TODO: fill in ] No trial registry record for the chronic low back pain Phase 3 trial was identified in the data provided.
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Painn = —

Sport and Spine Rehab Clinical Research Foundation·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combinationn = —

Muhammad Ilyas·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of ActiveMatrix on Spinal SSI Raten = —

Baylor College of Medicine·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Basivertebral Nerve Ablation With the Intracept Proceduren = —

Neuro Spine and Pain Center of Key West·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Painn = —

Universidad Complutense de Madrid·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Melatonin fOr CHronic bAck Pain (The MOCHA Trial)n = —

Odense University Hospital·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Nonpharmacologic Pain Management in FQHC Primary Care Clinicsn = —

University of Utah·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Melatonin for Patients With Chronic Low Back Painn = —

Bart Koes·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Painn = —

Mesoblast, Ltd.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trialn = —

Bart Koes·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Painn = —

Eli Lilly and Company·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Painn = —

Vertanical GmbH·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Functional Restoration for Chronic Low Back Pain: Medico-economic Impactn = —

Assistance Publique - Hôpitaux de Paris·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Mechanisms of Stimulation for Pain Alleviationn = —

Stanford University·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANTn = —

VA Office of Research and Development·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

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

University Hospital, Montpellier·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposuren = —

Northwestern University·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Painn = —

GCS Ramsay Santé pour l'Enseignement et la Recherche·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDDn = —

Fondazione Policlinico Universitario Campus Bio-Medico·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)n = —

Evon Medics LLC·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Painn = —

Eli Lilly and Company·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Modulation Effect of tACS on Chronic Low Back Painn = —

Massachusetts General Hospital·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depressionn = —

VA Office of Research and Development·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Dronabinol as an Adjunct for Reducing Painn = —

Christopher D. Verrico·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Psilocybin-Assisted Physical Therapy in Chronic Low Back Painn = —

Yale University·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trialn = —

VA Office of Research and Development·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Resilience Enhancement Following Sleep Treatmentn = —

University of Virginia·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Psilocybin Therapy for Chronic Low Back Painn = —

Joshua Woolley, MD, PhD·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Painn = —

Creative Medical Technology Holdings Inc·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

SA
Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain
Phase 4
Sport and Spine Rehab Clinical Research Foundation·Active, not recruiting·Primary completion 30 Mar 2019·NCT03888820
1 site
20 enrolledstalled · 2683d
MI
The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination
Phase 4
Muhammad Ilyas·Not yet recruiting·Primary completion 31 Oct 2024·NCT06401499
0 sites
BC
Efficacy of ActiveMatrix on Spinal SSI Rate
Phase 4
Baylor College of Medicine·Not yet recruiting·Primary completion 1 July 2025·NCT05297513
0 sites
NS
Basivertebral Nerve Ablation With the Intracept Procedure
Phase 4
Neuro Spine and Pain Center of Key West·ENROLLING_BY_INVITATION·Primary completion 1 Jan 2026·NCT05692440
1 site
PI: William Schnapp
UC
Percutaneous Electrical Nerve Stimulation As Alternative To Nerve Blocks In Anesthesia, Pain Medicine And Rehabilitation Of Nonspecific Chronic Pain
Phase 4
Universidad Complutense de Madrid·Not yet recruiting·Primary completion 1 Nov 2028·NCT07273006
1 site
PI: Juan Antonio Valera-Calero
OU
Melatonin fOr CHronic bAck Pain (The MOCHA Trial)
Phase 3
Odense University Hospital·Active, not recruiting·Primary completion 30 Apr 2026·NCT06476392
1 site
220 enrolled·PI: Karin Due Bruun
UO
Nonpharmacologic Pain Management in FQHC Primary Care Clinics
Phase 3
University of Utah·Active, not recruiting·Primary completion 31 Oct 2026·NCT04923334
2 sites
BK
Melatonin for Patients With Chronic Low Back Pain
Phase 3
Bart Koes·Recruiting·Primary completion 1 Dec 2026·NCT06859957
1 site
M.
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
Phase 3
Mesoblast, Ltd.·Active, not recruiting·Primary completion 1 July 2027·NCT06325566
40 sites
PI: Roger D Brown
BK
Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial
Phase 3
Bart Koes·Recruiting·Primary completion 1 Aug 2027·NCT06771492
1 site
EL
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Phase 3
Eli Lilly and Company·Recruiting·Primary completion 1 Sept 2027·NCT07035093
40 sites
PIs: Hemant Pandey, Nebojsa Skrepnik, Justin Yanuck, +36shared KOL · Layle +7
VG
Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain
Phase 3
Vertanical GmbH·Not yet recruiting·Primary completion 1 Nov 2027·NCT06956014
0 sites
AP
Functional Restoration for Chronic Low Back Pain: Medico-economic Impact
Phase 3
Assistance Publique - Hôpitaux de Paris·Not yet recruiting·Primary completion 31 July 2028·NCT07472374
1 site
PI: Johann Beaudreuil
SU
Mechanisms of Stimulation for Pain Alleviation
Phase 3
Stanford University·Recruiting·Primary completion 1 Aug 2028·NCT06741579
1 site·1 top centre: Stanford
PI: Jennifer Hah
VO
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Phase 3
VA Office of Research and Development·Not yet recruiting·Primary completion 1 June 2031·NCT07158567
2 sites
PI: Amy A Herrold, PhD BA
UH
Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive
PHASE2/PHASE3
University Hospital, Montpellier·Active, not recruiting·Primary completion 30 May 2022·NCT03737461
9 sites
113 enrolledstalled · 305d·PI: Christian CJ JORGENSEN
NU
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
Phase 2
Northwestern University·Active, not recruiting·Primary completion 1 June 2025·NCT05463367
1 site·1 top centre: Northwestern
60 enrolledstalled · 611d·PI: Apkar V Apkarian
GR
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
Phase 2
GCS Ramsay Santé pour l'Enseignement et la Recherche·Recruiting·Primary completion 1 Sept 2025·NCT06471998
1 site
30 enrolled
FP
Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD
Phase 2
Fondazione Policlinico Universitario Campus Bio-Medico·Recruiting·Primary completion 31 Oct 2025·NCT05066334
1 site
PI: Gianluca Vadalà
EM
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
Phase 2
Evon Medics LLC·Recruiting·Primary completion 30 Nov 2025·NCT06671132
2 sites
PIs: Charles Nwaokobia, Evaristus Nwulia, MD, MHS, Tanya Alim, +1
EL
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Phase 2
Eli Lilly and Company·Recruiting·Primary completion 1 Apr 2027·NCT05986292
64 sites·1 top centre: Northwestern
PIs: David DeAtkine, Shawn Searle, Louise Taber MD, +39
MG
Modulation Effect of tACS on Chronic Low Back Pain
Phase 2
Massachusetts General Hospital·Recruiting·Primary completion 1 Feb 2028·NCT06568198
1 site
VO
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Phase 2
VA Office of Research and Development·Recruiting·Primary completion 1 Dec 2028·NCT06419439
1 site
PI: Victoria D Powell
CD
Dronabinol as an Adjunct for Reducing Pain
Phase 2
Christopher D. Verrico·Recruiting·Primary completion 31 Dec 2028·NCT06454669
1 site
PI: Christopher D Verrico
YU
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Phase 2
Yale University·Not yet recruiting·Primary completion 1 June 2029·NCT07306364
1 site
PI: Joao De Aquino, M.D
VO
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
Phase 2
VA Office of Research and Development·Not yet recruiting·Primary completion 1 Oct 2029·NCT05935761
1 site
PIs: Jennifer C Naylor, Christine E. Marx, MD MA
UO
Resilience Enhancement Following Sleep Treatment
Phase 2
University of Virginia·Recruiting·Primary completion 30 Oct 2029·NCT07298941
1 site
PI: Patrick Finan, Ph.D
JW
Psilocybin Therapy for Chronic Low Back Pain
PHASE1/PHASE2
Joshua Woolley, MD, PhD·Recruiting·Primary completion 1 Apr 2026·NCT05351541
CT
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
PHASE1/PHASE2
Creative Medical Technology Holdings Inc·Recruiting·Primary completion 1 May 2026·NCT06053242