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Bone Marrow Aspirate Injection
Bone Marrow Aspirate Injection is a Cell therapy Biologic drug developed by Federal University of São Paulo. It is currently in Phase 3 development for Tissue regeneration and repair (specific indication under investigation in Phase 3 trial). Also known as: BMA, BM aspirate.
Bone marrow aspirate injection delivers autologous bone marrow-derived cells to promote tissue regeneration and repair through paracrine signaling and stem cell differentiation.
Bone marrow aspirate injection delivers autologous bone marrow-derived cells to promote tissue regeneration and repair through paracrine signaling and stem cell differentiation. Used for Tissue regeneration and repair (specific indication under investigation in Phase 3 trial).
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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 Aspirate Injection |
|---|---|
| Also known as | BMA, BM aspirate |
| Sponsor | Federal University of São Paulo |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
The procedure involves harvesting bone marrow from the patient, processing it to concentrate mononuclear cells and progenitor cells, and injecting the aspirate directly into damaged or diseased tissue. These cells secrete growth factors and cytokines that reduce inflammation, promote angiogenesis, and stimulate endogenous repair mechanisms. The autologous nature minimizes immunological rejection while leveraging the regenerative potential of bone marrow stem cells.
Approved indications
- Tissue regeneration and repair (specific indication under investigation in Phase 3 trial)
Common side effects
- Injection site pain or discomfort
- Infection at injection site
- Bleeding or hematoma
- Bone marrow harvest site pain
Key clinical trials
- AML/MDS Drug Sensitization by in Vivo Chemotherapy Administration
- Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis (PHASE3)
- Orthobiological Therapies in Musculoskeletal Disorders (EARLY_PHASE1)
- Bone Marrow Versus Adipose Tissue as a Cell Source for Infiltrative Treatment of Knee Osteoarthritis (NA)
- Biologic Injection For Adults With Lumbar Disc Herniation (NA)
- Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation (PHASE1)
- Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes (PHASE2)
- Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA (PHASE2, PHASE3)
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 Aspirate Injection CI brief — competitive landscape report
- Bone Marrow Aspirate Injection updates RSS · CI watch RSS
- Federal University of São Paulo portfolio CI
Frequently asked questions about Bone Marrow Aspirate Injection
What is Bone Marrow Aspirate Injection?
How does Bone Marrow Aspirate Injection work?
What is Bone Marrow Aspirate Injection used for?
Who makes Bone Marrow Aspirate Injection?
Is Bone Marrow Aspirate Injection also known as anything else?
What drug class is Bone Marrow Aspirate Injection in?
What development phase is Bone Marrow Aspirate Injection in?
What are the side effects of Bone Marrow Aspirate Injection?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: Federal University of São Paulo — full pipeline
- Therapeutic area: All drugs in Regenerative Medicine
- Indication: Drugs for Tissue regeneration and repair (specific indication under investigation in Phase 3 trial)
- Also known as: BMA, BM aspirate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing