Clinical trials: First Birth
Heart Failure With Reduced Ejection Fraction
First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that…
- Trial name
- CARDIOMESH (NCT03746938)
- Testing
- VB-C01
- Where
- 2 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Viscofan
Mesial Temporal Lobe Epilepsy
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
- Trial name
- GenTLE (NCT06063850)
- Testing
- AAV9-hSyn1-miGRIK2
- Where
- 18 sites in United States
- Volunteers
- 12 people
- Sponsor
- UniQure Biopharma B.V.
Locally Resectable Pediatrics Tumors
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06986811
- Testing
- Standard surgery, CEB-01
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- CEBIOTEX
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Contraception
LCS16 vs. COC User Satisfaction and Tolerability Study
To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.
- Trial name
- NCT03074045
- Testing
- Levonorgestrel (Kyleena, BAY86-5028), Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
- Where
- 9 sites in Russia
- Volunteers
- 145 people
- Sponsor
- Bayer
Overactive Bladder
Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
- Trial name
- NCT03874780
- Testing
- Vibe Delivery system
- Where
- 2 sites in Czechia, Portugal
- Volunteers
- 10 people
- Sponsor
- Vensica Therapeutics Ltd.
Glioblastoma Multiforme
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following…
- Trial name
- NCT00076986
- Testing
- IL13-PE38QQR, surgery and catheter placement (2 procedures), prolifespan 20 with carmustine implant (GLIADEL® Wafer)
- Where
- 60 sites in United States, Canada and 4 more
- Volunteers
- 300 people
- Sponsor
- INSYS Therapeutics Inc
First Metatarsophalangeal Joint Arthritis
Fusion Rates and Cost Analysis of Patients Undergoing 1st Metatarsal Phalangeal Joint Arthrodesis
This is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. These surgeons will collect data from X-rays, wound complications \and hardware complications.
- Trial name
- NCT03290586
- Testing
- Flower Cube
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- JEM Research Institute
Type 1 Diabetes Mellitus
VV-14300 for the Treatment of Type 1 Diabetes
This study is testing VV-14300 in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system.
- Trial name
- RELIEVE (NCT07831798)
- Testing
- VV-14300
- Where
- 2 sites in Canada, New Zealand
- Volunteers
- 29 people
- Sponsor
- Kriya Therapeutics, Inc.
Locally Advanced Soft Tissue Sarcoma, Recurrent Soft Tissue Sarcoma
First-in-man Clinical Trial of CEB-01 PLGA Membrane in Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma
This is an open label, first-in-man clinical trial to assess safety and tolerability of CEB-01 PLGA membrane in patients with recurrent or locally advanced retroperitoneal soft tissue sarcoma after surgery.
- Trial name
- NCT04619056
- Testing
- CEB-01 membrane loaded with SN-38
- Where
- 5 sites in Spain
- Volunteers
- 21 people
- Sponsor
- CEBIOTEX
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Aortic Aneurysm, Abdominal
Aorfix Intelliflex First in Human Study
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with…
- Trial name
- FIH-NZ (NCT02907762)
- Testing
- Endovascular aneurysm repair EVAR
- Volunteers
- 10 people
- Sponsor
- Lombard Medical
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Early-phase Safety and PK Study of a Vaginal Gel
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and…
- Trial name
- PPCM-01 (NCT07281404)
- Testing
- YASO GEL
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yaso Therapeutics Corporation
Contraception
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months.
- Trial name
- NCT01254292
- Testing
- Levonorgestrel IUD (LCS, BAY86-5028), Yasmin (EE30/DRSP, BAY86-5131)
- Where
- 94 sites in United States, Austria and 3 more
- Volunteers
- 567 people
- Sponsor
- Bayer
Tick Born Encephalitis
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
- Trial name
- NCT00387634
- Testing
- TBE vaccine for adults
- Where
- Czechia
- Volunteers
- 323 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Mitral Valve Insufficiency, Mitral Valve Disease
The Conveyor Study
To demonstrate that the Conveyor System can safely provide left ventricular access to deliver the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients who have been diagnosed with prior mitral…
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Trial name
- NCT03893578
- Testing
- Mitral valve-in-valve
- Volunteers
- 10 people
- Sponsor
- Synecor, LLC
Pancreatic Adenocarcinoma Non-resectable
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable.
- Trial name
- NCT07481383
- Testing
- ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003)
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Continuity Biosciences, LLC
Healthy Volunteers
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
- Trial name
- RaniPill (NCT03798912)
- Testing
- RaniPill capsule containing octreotide
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- RANI Therapeutics
Cesarean Delivery Procedures
KIRA Uterine Drain Device Evaluation- First-In- Human Study
The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor blood loss during and immediately after cesarean deliveries…
- Trial name
- RANI (NCT07387380)
- Testing
- Uterine drain for use in cesarean section
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lucie Medical Inc