Report scope. This 2026 Drug Asset Due Diligence Report evaluates Allogeneic human mesenchymal stem cells(University of Miami) as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
Allogeneic human mesenchymal stem cells(University of Miami) is a Mesenchymal stem cell therapy associated with its disclosed target and a global highest development stage of Phase 2. The lead disclosed indication is Aggression. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Allogeneic human mesenchymal stem cells(University of Miami)
- Target: its disclosed target
- Lead indication: Aggression
- Highest phase: Phase 2
- Matched trials: 11
- Matched result records: 6
- Matched asset deals: 0
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Allogeneic human mesenchymal stem cells(University of Miami), the MCP profile identifies its disclosed target as the primary target context and Aggression as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07512362 | Phase 2 | Recruiting | Not disclosed | Not disclosed |
| NCT06781333 | Phase 2 | Recruiting | Not disclosed | Not disclosed |
| NCT05522569 | Not Applicable | No longer available | Not disclosed | Not disclosed |
| NCT04776239 | Phase 1/2 | Completed | Not disclosed | Not disclosed |
| NCT04476901 | Phase 2 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT04040348 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT03487731 | Phase 1/2 | Withdrawn | Not disclosed | Not disclosed |
| NCT03058068 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02886884 | Phase 1/2 | Completed | Not disclosed | Not disclosed |
| NCT02675556 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT02398604 | Phase 1 | Terminated | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
3. Clinical readouts: what is known
Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.
Study: NCT04776239 (ACESO-IHD, CTgov). Phase: Phase 1/2. Enrollment: 26. Published: 2026-06-16.
Baseline(Mean) = 5.80 % | Baseline(Mean) = 4.28 %
A Phase I/II, Randomized, Double Blind, Pilot Trial to Evaluate the Safety and Efficacy of Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
Study: NCT02886884 (ACESO, CTgov). Phase: Phase 1/2. Enrollment: 16. Published: 2022-05-11.
Number of Treatment Emergent Serious Adverse Events (TE-SAEs) = 0 Treatment Emergent SAE | Number of Treatment Emergent Serious Adverse Events (TE-SAEs) = 0 Treatment Emergent SAE
A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty
Study: NCT02065245 (CRATUS, CTgov). Phase: Phase 1/2. Enrollment: 65. Published: 2021-04-27.
Infusion #1 = 0 Incidents | Infusion #1 = 0 Incidents
A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction.
Study: NCT02013674 (Trident, CTgov). Phase: Phase 2. Enrollment: 30. Published: 2020-02-05.
Number of Participants With Treatment-emergent Serious Adverse Events (SAE). = 0 Pts | Number of Participants With Treatment-emergent Serious Adverse Events (SAE). = 0 Pts
A Phase I/II, Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Dilated Cardiomyopathy.
Study: NCT01392625 (PoseidonDCM, CTgov). Phase: Phase 1/2. Enrollment: 37. Published: 2018-02-15.
Upper Respiratory Infection = 1 Pts | Upper Respiratory Infection = 0 Pts
A Phase I/II, Randomized Pilot Study of the Comparative Safety and Efficacy of Transendocardial Injection of Autologous Mesenchymal Stem Cells Versus Allogeneic Mesenchymal Stem Cells in Patients With Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction
Study: NCT01087996 (CTgov). Phase: Phase 1/2. Enrollment: 31. Published: 2015-05-27.
Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation = 6.70 % (95%CI, 1.70 - 31.95) | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation = 6.70 % (95%CI, 1.70 - 31.95)
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Allogeneic human mesenchymal stem cells(University of Miami) against approved therapies and clinical competitors in Aggression, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| No exact asset-specific transaction was returned. Use target-level precedents only as comparables and do not present them as asset transactions. | ||||
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-14. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
