Clinical trials: Cell Function
Type 1 Diabetes Mellitus
A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes
The objective of DIAGNODE-3 is to evaluate the efficacy and safety of three intranodal injections of 4 μg of Diamyd also known as retogatein compared to placebo, along with oral Vitamin D supplementation, to preserve endogenous…
- Trial name
- DIAGNODE-3 (NCT05018585)
- Testing
- Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®, Colecalciferol 2000 IU
- Where
- 60 sites in United States, Czechia and 7 more
- Volunteers
- 321 people
- Sponsor
- Diamyd Medical AB
Treatment of Type I Diabetes Mellitus.
Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients.
- Trial name
- NCT01947569
- Testing
- Biological
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- DiaVacs, Inc.
Recent Onset type1 Diabetes
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
Objectives The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve β-cell function and delay the progression of T1D in adolescent and adult patients.
- Trial name
- NCT04628481
- Testing
- Ladarixin
- Where
- 57 sites in United States, Belgium and 6 more
- Volunteers
- 289 people
- Sponsor
- Dompé Farmaceutici S.p.A
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks.
- Conditions
- To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disorders
- Trial name
- NCT04134299
- Testing
- AXA4010
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, Inc.
Poor Thymic Function, Immunodeficiency
Expanded Access Protocol Thymus Transplantation
The primary purpose is to provide access for patients who have immunodeficiency or severe autoimmune disease related to poor thymic function to cultured thymus tissue for implantation.
- Conditions
- Poor Thymic Function, Immunodeficiency, Athymia, Immunoreconstitution
- Trial name
- NCT02274662
- Testing
- Cultured Thymus Tissue, Blood Draw, Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus
- Volunteers
- 11 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
Type1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM)
- Trial name
- NCT04102202
- Testing
- BOL-DP-o-05
- Sponsor
- Breath of Life International Pharma Ltd
COPD, Interstitial Lung Disease
An Observational Outcomes Study for Autologous Cell Therapy Among Patients With COPD and Interstitial Lung Disease
The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient same-day.
- Trial name
- NCT03040674
- Testing
- Cell therapy
- Where
- United States
- Volunteers
- 489 people
- Sponsor
- Lung Institute
Diabetes Mellitus, Type 1
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
- Trial name
- NCT07222332
- Testing
- Baricitinib
- Where
- 131 sites in United States, Australia and 18 more
- Volunteers
- 300 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus
Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule
This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell…
- Trial name
- T1D OBTAIN (NCT06812988)
- Testing
- Brivekimig
- Where
- 24 sites in United States, Argentina and 6 more
- Volunteers
- 84 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on…
- Trial name
- FABULINUS (NCT06111586)
- Testing
- Frexalimab, Insulin
- Where
- 79 sites in United States, Austria and 14 more
- Volunteers
- 197 people
- Sponsor
- Sanofi
Sickle Cell Disease
Voxelotor Brain Oxygenation and Neurocognitive Study
This is an open label, single arm multicenter trial to evaluate the effect of voxelotor treatment on cerebral blood flow (CBF) and neurocognitive function in adolescent and young adult participants (12-30 years of age) with…
- Trial name
- NCT05228821
- Testing
- Voxelotor Oral Tablet
- Where
- 2 sites in United States
- Sponsor
- Pfizer
Muscular Dystrophies, Muscular Dystrophy, Duchenne
A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy
HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne Muscular Dystrophy (DMD).
- Conditions
- Muscular Dystrophies, Muscular Dystrophy, Duchenne, Muscular Disorders, Atrophic, Muscular Diseases
- Trial name
- HOPE-2 (NCT03406780)
- Testing
- CAP-1002
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- Capricor Inc.
Sickle Cell Disease
Voxelotor Neurocognitive Function Study
This is a Phase 3b, randomized, double-blind, placebo-controlled, multicenter study to assess the treatment effect of voxelotor on neurocognitive function as assessed by the National Institute of Health (NIH) Toolbox Cognition…
- Trial name
- NCT05228834
- Testing
- Voxelotor Only Product in Oral Dose Form
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
COPD, Interstitial Lung Disease
Autologous Stem Cell Treatment for Chronic Lung Disease Study
The purpose of the Lung Institute is to collect and isolate a patient's own cells and platelet rich plasma (PRP) and deliver the product back to the patient the same day.
- Trial name
- NCT03044431
- Testing
- Cell therapy
- Where
- United States
- Volunteers
- 207 people
- Sponsor
- Lung Institute
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.
Monogenic Disorders
Development of In Vitro Functional Assays From Primary Cells of Patients With Monogenic Diseases
The objective of this project is to build a collection of biological samples consisting of fibroblasts and primary keratinocytes from patients with orphan monogenic diseases and to use these cells in the customization of…
- Trial name
- OPERANDO (NCT03763864)
- Testing
- Skin Biopsy
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Apteeus