Clinical trials: Exosome
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
Squamous Cell Carcinoma of the Head and Neck
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab (Keytruda) in the front line setting, in patients with advanced and/or…
- Trial name
- NCT04453046
- Testing
- Hemopurifier, Pembrolizumab 200mg IV
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Aethlon Medical Inc.
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.
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.
Autoimmune Encephalitis, Early-stage Panencephalitis
Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
This is a prospective, non-randomized, observational registry study evaluating the clinical outcomes of patients with autoimmune or post-infectious neuroinflammatory syndromes receiving stem cell-derived biologics (including…
- Conditions
- Autoimmune Encephalitis, Early-stage Panencephalitis, Neuroinflammatory Demyelination
- Trial name
- NCT07145502
- Testing
- Allogeneic MSC infusions (IV)
- Where
- Poland
- Volunteers
- 76 people
- Sponsor
- Biocells Medical
Multiple Sclerosis
Allogeneic Mesenchymal Stem Cell-Derived Exosome Therapy for Progressive Multiple Sclerosis
The goal of this clinical trial is to learn if intravenous infusion of allogeneic mesenchymal stem cell (MSC)-derived exosomes can slow disability progression and improve neurological function in adults with progressive multiple…
- Trial name
- NCT07146087
- Testing
- MSC-Derived Exosomes
- Where
- Poland
- Volunteers
- 20 people
- Sponsor
- Biocells Medical
Alopecia Androgenica
Exosome Treatment and Hair Growth
This study investigates a novel exosome-based plant formulation for treating male pattern baldness (androgenetic alopecia), a condition that affects self-esteem and well-being.
- Trial name
- exosome (NCT06930326)
- Testing
- intradermal exosome, 0.9 % NaCl
- Where
- Malaysia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- COSMEDICIAN AP SDN BHD
Liver Cirrhosis
Using Autologous Bone Marrow Cells With Wharton Gel Exosomes to Stimulate Hepatic Cell Repair in Liver Cirrhosis
the study includes patients with liver cirrhosis irrespective of the stage excluding people with active tumor or other major health issue endangering life, the protocol includes the use of autologous bone marrow derived…
- Trial name
- bone marrow (NCT07374185)
- Testing
- Autologous Bone Marrow Aspirate Concentrate
- Where
- Iraq
- Volunteers
- 10 people
- Sponsor
- Global Stem Cell Center, Baghdad
Poor Ovarian Response, Female Infertility of Other Origin
Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF
Evaluating the Efficacy of Exosome-Enriched Culture Media to Enhance In Vitro Maturation and Embryo Development in Poor Ovarian Responders Undergoing IVF Summary: This is a prospective, randomized controlled trial designed to…
- Conditions
- Poor Ovarian Response, Female Infertility of Other Origin, Oocyte Immaturity
- Trial name
- EXOMAT (NCT07085312)
- Testing
- Exosome-Enriched IVF Culture
- Where
- Venezuela
- Volunteers
- 10 people
- Sponsor
- Fertiaguerrevere
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.
Premature Ovarian Insufficiency, Diminished Ovarian Reserve
A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)
The VL-POI-01 study is designed to evaluate the safety and efficacy of human placental mesenchymal stem cell derived exosome treatment in patients with premature ovarian insufficiency (POI) and diminished ovarian reserve.
- Trial name
- VL-POI-01 (NCT06072794)
- Testing
- VL-PX10
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Vitti Labs, LLC
COVID-19 Acute Respiratory Distress Syndrome, Respiratory Distress Syndrome
Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)
Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes.
- Trial name
- NCT05387278
- Testing
- EV-Pure™ and WJ-Pure™
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vitti Labs, LLC
Covid19, Corona Virus Infection
Expanded Access to Zofin for Patients With COVID-19
This expanded access protocol will provide access to the investigational product Zofin for patients in outpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or who are judged by a healthcare provider…
- Conditions
- Covid19, Corona Virus Infection, SARS (Severe Acute Respiratory Syndrome), Acute Respiratory Distress Syndrome
- Trial name
- NCT04657406
- Testing
- Zofin
- Sponsor
- ZEO ScientifiX, Inc.
COVID-19
Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans With Hemopurifier® Device
This is an Early Feasibility Study (EFS) investigating the use of the Hemopurifier® in the treatment of SARS-CoV-2 Virus Disease (COVID-19).
- Trial name
- NCT04595903
- Testing
- Hemopurifier
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Aethlon Medical Inc.
Prostate Cancer
Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle biopsy.
- Trial name
- NCT02702856
- Testing
- ExoIntelliScore Prostate
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Exosome Diagnostics, Inc.
COVID-19
Zofin to Treat COVID-19 Long Haulers
The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (> 6 weeks and < 24 months) of COVID-19.
- Trial name
- NCT05228899
- Testing
- Zofin
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- ZEO ScientifiX, Inc.
Corona Virus Infection, COVID-19
Zofin (Organicell Flow) for Patients With COVID-19
The purpose of this research study is to evaluate the safety and potential efficacy of Intravenous Infusion of Zofin for treatment of moderate to severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs Placebo.
- Conditions
- Corona Virus Infection, COVID-19, SARS, Acute Respiratory Distress Syndrome
- Trial name
- NCT04384445
- Testing
- Zofin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ZEO ScientifiX, Inc.
Low Back Pain
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain
This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.
- Trial name
- NCT06361485
- Testing
- Lumbar Injections with 10cc's of Wharton's Jelly Allograft
- Where
- 4 sites in United States
- Volunteers
- 100 people
- Sponsor
- R3 Stem Cell
Urologic Cancer
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a…
- Trial name
- NCT04720599
- Testing
- ExoDx Prostate(IntelliScore)
- Where
- 3 sites in United States, Germany
- Volunteers
- 120 people
- Sponsor
- Exosome Diagnostics, Inc.
Acute Respiratory Distress Syndrome, ARDS
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with…
- Trial name
- NCT05354141
- Testing
- ExoFlo, Intravenous normal saline
- Where
- 32 sites in United States
- Volunteers
- 970 people
- Sponsor
- Direct Biologics, LLC