ClinicalTrials.gov record NCT07471074

Phenotypic and Functional Study of Bone Marrow Mesenchymal Stem Cells in Waldenström Macroglobulinemia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Phenotypic and Functional Study of Bone Marrow Mesenchymal Stem Cells in Waldenström Macroglobulinemia

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional screening study collects bone marrow samples from adults with Waldenström Macroglobuloinemia and from healthy volunteers to study mesenchymal stem cells (MSCs). It compares MSC gene expression, growth/ culture behavior and cell adhesion, and looks for a CXCL12 genetic variant. The study is non-randomized, parallel groups, and unmasked.

What it is studying. The study is testing whether MSCs from people with Waldenström Macroglobuloinemia differ from MSCs from healthy volunteers in their transcriptome (gene expression), in how they grow and survive in culture (including bulk versus sorted cell methods), and in cell adhesion properties. It also examines the CXCL12 -801GA polymorphism in participants.

What the researchers hope to learn. Scientific goals: compare MSC transcriptomes between groups; compare MSC culture methods (bulk versus post-sort) for viability and characterization; measure differences in MSC cell adhesion; and assess the CXCL12 (-801GA) polymorphism.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Waldenström disease (WM) is defined by the presence of bone marrow lymphoplasmocytes and monoclonal immunoglobulin M (IgM). Treatment should be initiated in cases of cytopenia, tumor syndrome or when the physicochemical or immunological properties of IgM explain the occurrence of amyloidosis, cryoglobulin or neurological manifestations, which have already been extensively studied. The disease is characterized by a MYD88 emutation found in 90% of patients. However, the molecular landscape is complex: the other most frequent anomaly is a mutation in CXCR4, found in 30% of patients. This is a chronic, relapsing-remitting disease involving cells of the B lymphoid lineage, whose behavior is normally influenced by the presence of their specific target and signals from their environment. Indeed, around WM tumor cells, numerous lymphocyte population abnormalities have been reported (excess of atypical extra follicular B lymphocytes, decrease in naive B, T or NK populations, increase in certain suppressive subpopulations (Treg, TFH). In a mouse model, excess Tregs cells appear to interact with WM cells via the CD40/CD40ligand axis. Mast cells may also promote proliferation of WM malignant cells via the same axis. Myeloid and monocytic populations have an inflammatory profile. Furthermore, increased angiogenesis may counteract the effects of bone marrow hypoxia (which itself prevents WM cell proliferation and adhesion to mesenchymal cells). In addition, several cytokines probably play an important role: CXCL12, highly expressed in the marrow of WM patients, may play a role due to the high frequency of CXCR4 activating mutations. CXCL12 is also involved in the adhesion of WM cells to fibronectin. WM cells have increased expression of Very late antigen-4 (VLA4), which co-interacts with CXCR4 and promotes WM cell adhesion to medullary mesenchymal stem cells (MSCs) and endothelial cells. The CCL5/GLI2/IL6 axis also appears to be important. Other factors have also been suggested: Interleukin 21, Blys and abnormal angiogenic factors. MSCs could play an important role in these multiple cellular \& extracellular factors via CCL5, then IL6. CXCL12, activation of the Eph-B2-(expressed by WM cells) Ephrin B2 (expressed by MSCs) pathway. The role of MSCs and abnormalities in these cells has already been recognized in certain leukemias, leading to therapeutic strategies that are now envisaged to target not the neoplastic cell but its microenvironment. However, in WM, the interactions between these cells and the clonal cells of the disease remain unknown today. cellular factors via CCL5, then IL6. CXCL12, activation of the Eph-B2-(expressed by WM cells) Ephrin B2 (expressed by MSCs) pathway.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Genetic
  • sample of bone marrow cells

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients with WM, meeting the diagnostic criteria defined at the 2nd WM Workshop, revised at the 9th international workshop.
  • Patients requiring treatment within 3 months according to the recommendations defined at the 2nd Workshop on WM.
  • Patients having given their consent for this study.
  • Affiliation to a social security scheme.

Exclusion criteria

  • Patients with other chronic lymphoid hemopathies. Particular care should be taken to exclude other closely related lymphoplasmacytic proliferations, especially marginal zone lymphomas.
  • Patients with WM who have undergone histological transformation to a lymphoma other than diffuse large B- cell lymphoma.
  • Absence of consent for this study.
  • Patients under court protection, subjects participating in another study with an exclusion period still in progress at pre-inclusion.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will provide medical information from a hemopathy/hematology form and give a 5 mL bone marrow sample for study of mesenchymal stem cells (MSCs). Laboratory analyses will include genetic testing for the CXCL12 (-801GA) polymorphism and MSC studies such as transcriptome and culture comparisons between WM patients and healthy volunteers. Healthy volunteers will provide the same bone marrow sample for comparison. The record lists primary outcome analyses over a 2‑year timeframe; other visit schedules, procedures, or participant services are not specified in the registry entry.

How the study is structured. Interventional screening study with two parallel, non-randomized groups (people with Waldenström Macroglobuloinemia and healthy volunteers). Participants provide clinical information and a bone marrow sample (about 5 ml) for MSC study and genetic testing. The study is not masked (no blinding).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 10, 2026
Primary completion
March 2028 (estimated)
Study completion
March 2028 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Mar 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Centre Hospitalier Universitaire, Amiens

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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