Last reviewed · How we verify
autologous cell-based delivery
autologous cell-based delivery is a Biologic drug developed by Timothy J Nelson, MD, PhD. It is currently in Phase 1 development. Also known as: umbilical cord blood derived mononuclear cells.
Autologous cell-based delivery involves the transplantation of autologous bone marrow mononuclear cells (ABMMC) or autologous stem cells, which have been studied in various clinical trials for conditions such as acute myocardial infarction, metastatic osteosarcoma, and diffuse large B-cell lymphoma. The mechanism of autologous cell-based delivery is related to the exogenous expression of the ADA gene, which is achieved through the use of a retroviral vector encoding the human ADA cDNA sequence.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 cell-based delivery |
|---|---|
| Also known as | umbilical cord blood derived mononuclear cells |
| Sponsor | Timothy J Nelson, MD, PhD |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- 33300-Febrile neutropenia
- Mucositis oral
- Nausea
- Neutropenic Fever
- Mucositis
- 13500-Anorexia
- 43100-Hypokalemia
- Diarrhea
- Febrile neutropenia
- Anorexia
- 65800-Platelet count decreased
- Hypokalemia
Key clinical trials
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- A Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Study Participants With HRD-negative Epithelial Ovarian Cancer (NA)
- Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation (EARLY_PHASE1)
- This Clinical Trial is a Single-arm, Non-randomized Pilot Trial to Determine the Safety of Administering Autologous Anti-C19 Cells (ARI-0001) and the Feasibility of Local CAR-T Cell Production in Patients Over 18 Years of Age With Relapsed/Refractory (R/R) CD19+ Hematologic Malignancies, Including R (NA)
- A Positive Psychology Based Intervention (PATH-C) for Caregivers of HSCT Survivors (NA)
- Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma (PHASE1)
- Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin (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:
- autologous cell-based delivery CI brief — competitive landscape report
- autologous cell-based delivery updates RSS · CI watch RSS
- Timothy J Nelson, MD, PhD portfolio CI
Frequently asked questions about autologous cell-based delivery
What is autologous cell-based delivery?
Who makes autologous cell-based delivery?
Is autologous cell-based delivery also known as anything else?
What development phase is autologous cell-based delivery in?
What are the side effects of autologous cell-based delivery?
Related
- Manufacturer: Timothy J Nelson, MD, PhD — full pipeline
- Also known as: umbilical cord blood derived mononuclear cells
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing