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Autologous monocytes
Autologous monocytes is a Cell therapy; autologous cellular immunotherapy Biologic drug developed by Aivita Biomedical, Inc.. It is currently in Phase 3 development for Diabetic foot ulcers (Phase 3).
Autologous monocytes are a patient's own immune cells that are isolated, potentially modified or activated ex vivo, and reinfused to enhance immune function and promote tissue repair.
Autologous monocytes are a patient's own immune cells that are isolated, potentially modified or activated ex vivo, and reinfused to enhance immune function and promote tissue repair. Used for Diabetic foot ulcers (Phase 3).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Autologous monocytes |
|---|---|
| Sponsor | Aivita Biomedical, Inc. |
| Drug class | Cell therapy; autologous cellular immunotherapy |
| Modality | Biologic |
| Therapeutic area | Immunology; Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
This cell therapy leverages the patient's own monocytes—innate immune cells with roles in inflammation, phagocytosis, and tissue remodeling—by harvesting them, processing them (potentially with activation or differentiation signals), and returning them to the patient to augment immune responses or promote healing. The mechanism likely involves enhanced antimicrobial activity, clearance of damaged tissue, and secretion of immunomodulatory cytokines.
Approved indications
- Diabetic foot ulcers (Phase 3)
Common side effects
- Injection site reactions
- Fever
- Infection
Key clinical trials
- Efficacy of Autologous Conditioned Serum in Temporomandibular Joint Disorder (NA)
- IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma (PHASE1)
- Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer (PHASE1)
- A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) for Multiple Sclerosis (PHASE2)
- Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R (PHASE2)
- hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) (PHASE2)
- Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases (PHASE2)
- Topical Versus Injection PRP for Olfactory Dysfunction (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:
- Autologous monocytes CI brief — competitive landscape report
- Autologous monocytes updates RSS · CI watch RSS
- Aivita Biomedical, Inc. portfolio CI
Frequently asked questions about Autologous monocytes
What is Autologous monocytes?
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Related
- Drug class: All Cell therapy; autologous cellular immunotherapy drugs
- Manufacturer: Aivita Biomedical, Inc. — full pipeline
- Therapeutic area: All drugs in Immunology; Regenerative Medicine
- Indication: Drugs for Diabetic foot ulcers (Phase 3)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing