Table 4 Promising extracellular vesicle-based therapy-related interventional studies
Candidate | Condition | Approval | Source | Engineered | Phase | Sponsor | NCT No. |
|---|---|---|---|---|---|---|---|
ExoFlo(DB-2Q) | ARDS | U.S. FDA | bmMSCs | - | Phase 3 | Direct Biologics, LLC | 05354141 |
ExoFlo(DB-3Q) | Crohn’s disease | U.S. FDA | bmMSCs | - | Phase 1 Phase 2 | Direct Biologics, LLC | 05836883 |
ExoFlo(DB-3Q) | Crohn’s disease | U.S. FDA | bmMSCs | - | Phase 1 | Direct Biologics, LLC | 05130983 |
DB-3Y | Refractory ulcerative colitis | U.S. FDA | bmMSCs | - | Phase 1 | Direct Biologics, LLC | 05176366 |
AGLE-102 | Dystrophic epidermolysis bullosa | U.S. FDA | bmMSCs | COL7 COL7A1 | Phase 1 Phase 2 | Aegle Therapeutics | 04173650 |
AGLE-102 | Burn wounds | U.S. FDA | bmMSCs | COL7 COL7A1 | Phase 1 | Aegle Therapeutics | 05078385 |
BRE-AD01(BxC-I17e) | Atopic dermatitis | U.S. FDA | Stem cells | - | Phase 1 | Brexogen Inc. | 06055361 |
ILB-202 | Inflammation | HREC (Australia) | - | superrepressor IκBα | Phase 1 | ILIAS Biologics | 05843799 |
Zofin | COVID-19 | U.S. FDA | Human amniotic fluid | - | Phase 1 Phase 2 | ZEO ScientifiX, Inc. | 05228899 |
Ardoxso | COVID-19 and ARDS (coronavirus pneumonia) | U.S. FDA | MSCs | - | Phase 1 Phase 2 | AVEM HealthCare | 04798716 |
PEP | Diabetic foot ulcers | U.S. FDA | Platelets | - | Phase 2 | Rion Inc. | 06319287 |
PEP | Knee osteoarthritis | U.S. FDA | Platelets | - | Phase 1 | Rion Inc. | 06463132 |
EXOB-001 | Bronchopulmonary dysplasia | U.S. FDA EMA(Europe) | ucMSCs | - | Phase 1 Phase 2 | EXO Biologics S.A. | 06279741 |
SNE-101 | Stroke | MFDS (Korea) | ucMSCs | - | Phase 1b | S&E bio | NA |
AB126 | Acute ischemic stroke | U.S. FDA | Neural cells | - | Phase 1b/2a | Aruna Bio | NA |
XoGloPro | COVID-19 | U.S. FDA | Placenta MSCs | - | Phase 1a | Kimera Labs | NA |
