Clinical trials: Extracellular Vesicles
Acute Ischemic Stroke AIS
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke
- Trial name
- STEVIA (NCT06995625)
- Testing
- SNE-101
- Where
- 3 sites in South Korea
- Volunteers
- 18 people
- Sponsor
- S&Ebio Co. Ltd.
Impaired Glucose Tolerance
Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance
- Trial name
- NCT06495437
- Testing
- Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.
- Volunteers
- 20 people
- Sponsor
- BEAUTECH
COVID-19
Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19
Early Mild Outpatient infusion Therapy with ExoFloTM for COVID-19 (EMOTE COVID-19) To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles…
- Trial name
- NCT05125562
- Testing
- ExoFlo
- Sponsor
- Direct Biologics, LLC
Perianal Fistula Due to Crohn's Disease
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing…
- Trial name
- NCT06918808
- Testing
- DB-3Q
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Direct Biologics, LLC
COVID-19, ARDS
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients…
- Trial name
- EXIT-COVID19 (NCT04493242)
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 6 sites in United States
- Volunteers
- 102 people
- Sponsor
- Direct Biologics, LLC
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
Dystrophic Epidermolysis Bullosa
MSC EVs in Dystrophic Epidermolysis Bullosa
INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs).
- Trial name
- NCT04173650
- Testing
- AGLE-102
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Aegle Therapeutics
Pancreas Cancer, Exosomes
ExoLuminate Study for Early Detection of Pancreatic Cancer
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).
- Conditions
- Pancreas Cancer, Exosomes, Extracellular Vesicles, Pancreatic Neoplasms
- Trial name
- NCT05625529
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Biological Dynamics
Knee Osteoarthritis
Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the…
- Trial name
- NCT06463132
- Testing
- PEP/Euflexxa, PEP
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rion Inc.
Duchenne Muscular Dystrophy (DMD)
Safety and Dystrophin Expression of SPOT-03 in Duchenne Muscular Dystrophy (DMD) Patients
The primary objective of this study is to evaluate the safety and tolerability of SPOT-03 administered by intravenous (IV) infusion to DMD patients.
- Trial name
- NCT07188012
- Testing
- SPOT-03
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai Siponuoyin Biotechnology Co Ltd
COVID-19
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
Investigational New Drug trial investigating safety as primary endpoint and clinical efficacy as secondary endpoint of placental, mesenchymal stem cell-derived extracellular vesicles for the treatment of COVID-19 symptoms in…
- Trial name
- NCT07664696
- Testing
- IV infusion using an isolated, placental, mesenchymal stem cell derived EVs
- Volunteers
- 64 people
- Sponsor
- Kimera Labs Inc.
Perianal Fistula, Crohn's Disease
Study of ExoFlo for the Treatment of Perianal Fistulas
To evaluate the safety and feasibility of ExoFlo as a treatment for Perianal Fistulizing Crohn's Disease.
- Trial name
- NCT05836883
- Testing
- ExoFlo, Local injection of normal saline
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Direct Biologics, LLC
Breast Neoplasm
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a…
- Trial name
- NCT06672302
- Testing
- ExoPred
- Where
- 3 sites in United States, South Korea
- Volunteers
- 330 people
- Sponsor
- EXoPERT
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Covid19, Postviral Syndrome
ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome
This is a Phase I/II trial to evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EV), ExoFlo, as treatment for Post-Acute COVID-19 and Chronic…
- Conditions
- Covid19, Postviral Syndrome, Dyspnea
- Trial name
- NCT05116761
- Testing
- Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles, Saline
- Sponsor
- Direct Biologics, LLC
Androgenetic Alopecia
XVIE to Treat Androgenetic Alopecia (AGA)
This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss).
- Trial name
- NCT07482423
- Testing
- Decellularized allogeneic human amniotic fluid, Sodium chloride 0.9% injectable solution
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Restore Biologics Holdings, Inc. dba Xtressé
Ulcerative Colitis, Inflammatory Bowel Diseases
Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis
Protocol Summary Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory ulcerative…
- Trial name
- NCT05176366
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Direct Biologics, LLC
Psoriasis
Safety and Tolerability Study of MSC Exosome Ointment
This phase 1 study aims to evaluate the safety and tolerability of the application of the MSC exosome ointment with repeated topical application on adult healthy subjects (TID from Day 1 to 20).
- Trial name
- NCT05523011
- Testing
- Exosome ointment
- Where
- Singapore
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Paracrine Therapeutics Dermatology Pte. Ltd.
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Extracellular Vesicles
Isolation and Characterization of the Extracellular Vesicles Secreted by the Human Endometrium
The main aim of this study is to describe the morphology, size distributions and specific markers of the different vesicles populations present in the human endometrial fluid.
- Trial name
- NCT02797834
- Testing
- Endometrial fluid collection
- Where
- Spain
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Igenomix