Last reviewed · How we verify
Bone marrow mesenchymal stem cells
Bone marrow mesenchymal stem cells is a Cell therapy Small molecule drug developed by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia. It is currently in Phase 3 development for Tissue regeneration and repair (specific indications in phase 3 trials not fully specified in available data). Also known as: Chondrochymal®.
Bone marrow mesenchymal stem cells differentiate and engraft into damaged tissues to promote regeneration, reduce inflammation, and restore tissue function.
Bone marrow mesenchymal stem cells are being studied in clinical trials for conditions such as multiple sclerosis, perianal Crohn disease, and perianal fistula. The exact mechanism of action of bone marrow mesenchymal stem cells is currently unknown.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Bone marrow mesenchymal stem cells |
|---|---|
| Also known as | Chondrochymal® |
| Sponsor | Federal Research Clinical Center of Federal Medical & Biological Agency, Russia |
| Drug class | Cell therapy |
| Modality | Small molecule |
| Therapeutic area | Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
Mesenchymal stem cells (MSCs) are multipotent cells harvested from bone marrow that can differentiate into various cell types (osteocytes, chondrocytes, adipocytes) and secrete immunomodulatory and anti-inflammatory cytokines. Upon transplantation, they home to damaged tissues, replace lost cells, and create a regenerative microenvironment. This mechanism supports tissue repair and functional recovery in degenerative or traumatic conditions.
Approved indications
- Tissue regeneration and repair (specific indications in phase 3 trials not fully specified in available data)
Common side effects
- Injection site reactions
- Fever
- Infection risk
- Immune response
Key clinical trials
- Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue (PHASE1)
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (PHASE3)
- Phenotypic and Functional Study of Bone Marrow Mesenchymal Stem Cells in Waldenström Macroglobulinemia (NA)
- Study of Mesenchymal Autologous Stem Cells as Regenerative Treatment for Multiple Sclerosis (PHASE1, PHASE2)
- A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle (PHASE3)
- MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma (PHASE1)
- Orthobiological Therapies in Musculoskeletal Disorders (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bone marrow mesenchymal stem cells CI brief — competitive landscape report
- Bone marrow mesenchymal stem cells updates RSS · CI watch RSS
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia portfolio CI
Frequently asked questions about Bone marrow mesenchymal stem cells
What is Bone marrow mesenchymal stem cells?
How does Bone marrow mesenchymal stem cells work?
What is Bone marrow mesenchymal stem cells used for?
Who makes Bone marrow mesenchymal stem cells?
Is Bone marrow mesenchymal stem cells also known as anything else?
What drug class is Bone marrow mesenchymal stem cells in?
What development phase is Bone marrow mesenchymal stem cells in?
What are the side effects of Bone marrow mesenchymal stem cells?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia — full pipeline
- Therapeutic area: All drugs in Regenerative Medicine
- Indication: Drugs for Tissue regeneration and repair (specific indications in phase 3 trials not fully specified in available data)
- Also known as: Chondrochymal®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing