Clinical trials: ALLOGRAFT
Kidney Transplant Rejection
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®.
- Trial name
- KOAR (NCT03326076)
- Testing
- Donor-derived cell-free DNA (AlloSure®), Standard care, Peripheral blood gene expression profiling (AlloMap Kidney)
- Where
- 72 sites in United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- CareDx
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Diabetic Foot Ulcers, Wound Care
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical.
- Trial name
- NCT02120755
- Testing
- AmnioClear™ Human Allograft Amniotic Membrane
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Liventa Bioscience
Presbyopia
Safety and Efficacy of an Intrastromal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
- Trial name
- NCT03671135
- Testing
- TCA Intrastromal Inlay
- Where
- 4 sites in Belgium, Ireland and 1 more
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Allotex, Inc.
Degenerative Disc Disease
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
- Trial name
- VAST (NCT03709901)
- Testing
- Active Allograft
- Where
- 13 sites in United States
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- VIVEX Biologics, Inc.
Transplant
Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient
The primary objective of the study is to assess the impact of AlloCare mHealth remote monitoring on the early post-transplant period in solid organ transplantation.The outcome measure for primary objective is overall reduction in…
- Trial name
- TEAMMATE (NCT05033548)
- Where
- 10 sites in United States
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- CareDx
Chronic Effect of Ultraviolet Radiation on Photoaged Skin, Dermatologic Disorders
Safety Study of Bone Marrow Derived Stem Cells on Patients With Cutaneous Photoaging
The purpose of this study is to determine whether a one-time injection of allogeneic mesenchymal bone marrow cells is safe and beneficial in the treatment of photodamage on the face.
- Trial name
- NCT01771679
- Testing
- Allogeneic Mesenchymal Bone Marrow Cells
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Stemedica Cell Technologies, Inc.
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
Surgical Wound, Herniation
Efficacy of a Full-Thickness Placental Allograft in Lumbar Microdiscectomy
To evaluate the efficacy of full thickness placental allograft use in Microdiscectomy application. To evaluate post-microdiscectomy reherniation rate in patients treated with full-thickness placental allografts.
- Trial name
- NCT03536013
- Testing
- Other: Full-thickness placental allograft
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- StimLabs
Lung Transplant Rejection
Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI
This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129.
- Trial name
- NCT04941573
- Testing
- Hyperpolarized 129-Xenon (MagniXene) MRI of the lung
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Xemed LLC
Presbyopia, Refractive Errors
Safety and Efficacy of a Sub-epitheilal Transform™ Corneal Allograft (TCA) for Presbyopia Correction
The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.
- Trial name
- NCT03675438
- Testing
- Sub-epitheilal TCA Inlay
- Where
- 11 sites in Austria, Belgium and 4 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- Allotex, Inc.
Transplant;Failure,Kidney
Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients
Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier.
- Trial name
- QIDNEY (NCT03765203)
- Testing
- Natera KidneyScan, Clinical Performance and Value Vignettes
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Graft Rejection, Lung Disease
Lung Allograft Rejection Gene Expression Observational (LARGO) Study
The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with…
- Trial name
- LARGO (NCT00751309)
- Testing
- Non-interventional
- Where
- 20 sites in United States, Austria and 3 more
- Volunteers
- 2,044 people, healthy volunteers welcome
- Sponsor
- XDx
Kidney Transplant Rejection
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance
Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes.
- Trial name
- ADMIRAL (NCT04566055)
- Testing
- AlloSure
- Where
- 8 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- CareDx
Graft Rejection, Heart Disease
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test.
- Trial name
- CARGOII (NCT00761787)
- Where
- 17 sites in United States, Austria and 9 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- XDx
Osteoarthritis, Tendinitis
Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions.
- Conditions
- Osteoarthritis, Tendinitis, Sports Injury, Degenerative Disc Disease
- Trial name
- NCT03390920
- Testing
- Umbilical Allograft
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- R3 Stem Cell
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
Presbyopia
Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up
The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.
- Trial name
- NCT06310252
- Testing
- Opthalmic assessments
- Where
- 7 sites in Czechia, Ireland and 2 more
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Allotex, Inc.
Rotator Cuff Tear, Fatty Atrophy
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction.
- Trial name
- NCT03379324
- Testing
- Superiority of augmented repairs, Fat degeneration of supraspinatus muscle
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Applied Biologics, LLC
Hyperopia
Safety and Efficacy of the Transform™ Corneal Allograft for Hyperopia Correction
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects.
- Trial name
- NCT03671096
- Testing
- Intrastromal TCA Inlay
- Where
- 11 sites in Austria, Belgium and 4 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- Allotex, Inc.