Clinical trials: Defects
DiGeorge Anomaly
Serum-Free Thymus Transplantation in DiGeorge Anomaly
The study purpose is to determine if thymus tissue cultured in a serum-free (SF) solution is a safe and effective treatment for atypical and typical complete DiGeorge anomaly. [Funding Source - FDA OOPD]
- Trial name
- SerumFree (NCT00849888)
- Testing
- Serum Free Thymus Transplantation with Immunosuppression, Serum Free Thymus Transplantation without immunosuppression
- Volunteers
- 2 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Alagille Syndrome
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US.
- Trial name
- NCT04530994
- Testing
- maralixibat
- Where
- 14 sites in United States
- Sponsor
- Mirum Pharmaceuticals, Inc.
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Knee Cartilage Defects
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis.
- Trial name
- CARTISTEM23-01 (NCT07339111)
- Testing
- CARTISTEM® + Debridement, Debridement
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medipost, Inc.
Increased Lordosis/Scoliosis, Hyporeflexia
Biomarker for Duchenne Muscular Dystrophy
International, multicenter, observational, longitudinal study to identify biomarker/s for Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.
- Conditions
- Increased Lordosis/Scoliosis, Hyporeflexia, Duchenne Muscular Dystrophy, Red-Green Color Blindness
- Trial name
- BioDuchenne (NCT02994030)
- Where
- 12 sites in Albania, Egypt and 6 more
- Volunteers
- 103 people
- Sponsor
- CENTOGENE GmbH Rostock
Coronary Artery Disease
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI
The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-Imaging to detect defects in the supply of blood to the heart muscle (myocardial…
- Trial name
- ASPECT (NCT00990327)
- Testing
- Apadenoson SPECT-MPI, Adenosine SPECT-MPI
- Where
- 122 sites in United States, Brazil
- Volunteers
- 863 people
- Sponsor
- Forest Laboratories
Periodontal Diseases
Regenafil Versus Demineralized Freeze Dried Bone Allograft (DFDBA) for Periodontal Defects
The purpose of this research study was to determine whether treatment with the bone grafting material Regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (DFDBA).
- Trial name
- NCT00255970
- Testing
- DFDBA, Regenafil
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RTI Surgical
Soft Tissue Defects, Soft Tissue Wounds
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
- Conditions
- Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect
- Trial name
- COVER (NCT07385313)
- Testing
- Myriad™ applied in conjunction with NPWT, NPWT Alone
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Aroa Biosurgery Limited
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Arrhythmogenic Right Ventricular Cardiomyopathy
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
- Trial name
- RIDGE-1 (NCT06228924)
- Testing
- TN-401
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- Tenaya Therapeutics
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Knee Injury
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).
- Trial name
- NCT00984594
- Testing
- Primary injury site, Backfill site
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- RTI Surgical
Articular Cartilage Defects
Extension Study for Participants of MACI00206 Study of MACI® for the Treatment of Symptomatic Articular Cartilage Defects of the Knee
To examine the 5-year efficacy and safety of MACI implant, compared with arthroscopic microfracture, in participants who received study treatment in the SUMMIT study for treatment of symptomatic articular cartilage defects of the…
- Trial name
- Extension (NCT01251588)
- Testing
- autologous cultured chondrocytes on porcine collagen membrane, Microfracture
- Where
- 14 sites in Czechia, France and 5 more
- Volunteers
- 128 people
- Sponsor
- Vericel Corporation
Disorder of Soft Tissue of Body Wall Region
Investigation of A-ECM for the Correction of Soft Tissue Defects
Soft tissue injury leads to significant deformity in size, shape and body contour. Adipose tissue, continues to be the tissue of choice in repairing soft tissue defects due to traumatic or other defects.
- Trial name
- NCT01992315
- Testing
- Adipose-derived ECM
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aegeria Soft Tissue LLC
Articular Cartilage Disorder, Degeneration; Articular Cartilage
Chondrofix Osteochondral Allograft Prospective Study
The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee.
- Conditions
- Articular Cartilage Disorder, Degeneration; Articular Cartilage, Chronic Cartilage Injury, Acute Cartilage Injury
- Trial name
- NCT01410136
- Testing
- Chondrofix Osteochondral Allograft
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- Zimmer Orthobiologics, Inc.
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Corneal Epithelial Defect
ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. The study included two experimental groups (low-dose ZKY001 eye drops group and medium-dose ZKY001 eye drops group) and a placebo control…
- Trial name
- NCT06213727
- Testing
- lowe-dose ZKY001 eye drops, Medium-dose ZKY001 eye drops, ZKY001 simulated eye drops
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.