Clinical trials: Disorder Related to Transplantation
For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling
A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person).
- Conditions
- For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling, For Recipients, Acute Myelogenous Leukemia (AML)
- Trial name
- NCT02200380
- Testing
- CDX-301, CDX-301 and plerixafor
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Celldex Therapeutics
Hematologic Diseases, Hematologic Malignancies
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related…
- Trial name
- NCT00993486
- Testing
- Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- Kiadis Pharma
Age-Related Macular Degeneration
Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD
To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.
- Trial name
- PORTRAY (NCT02563782)
- Testing
- Sub-retinal transplantation of MA09-hRPE cells, tacrolimus and mycophenolate mofetil
- Where
- United States
- Sponsor
- Astellas Institute for Regenerative Medicine
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
Age-Related Macular Degeneration
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD
The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from one to five years following the surgical…
- Trial name
- NCT02463344
- Testing
- MA09-hRPE
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Institute for Regenerative Medicine
Dry Age Related Macular Degeneration
Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age Related Macular Degeneration (AMD) and to…
- Trial name
- Dry AMD (NCT01344993)
- Testing
- MA09-hRPE
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Astellas Institute for Regenerative Medicine
Hepatocellular Carcinoma
A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation
Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver…
- Trial name
- NCT02686372
- Testing
- TCR-T, No intervention and TCR-T (at crossover)
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Lion TCR Pte. Ltd.
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Hemorrhage
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection…
- Trial name
- NCT02204930
- Testing
- PeproStat
- Where
- 4 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Haemostatix Ltd
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT01794299
- Testing
- ATIR
- Where
- 8 sites in Belgium, Canada and 2 more
- Volunteers
- 31 people
- Sponsor
- Kiadis Pharma
Multiple Myeloma
A Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this protocol can participate.
- Trial name
- QoLMMBuS (NCT02946333)
- Where
- 65 sites in Spain
- Volunteers
- 355 people
- Sponsor
- Celgene
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Infection
HBV-associated Liver Transplant(LT) Patients by IV Injecting GC1102
This is a clinical study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT03519113
- Testing
- GC1102 80,000 IU, GC1102 100,000 IU, I.V HBIG
- Where
- South Korea
- Volunteers
- 186 people
- Sponsor
- Green Cross Corporation
Lung Neoplasms, Disorder Related to Lung Transplantation
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants.
- Trial name
- BREATH (NCT01793246)
- Testing
- probe based laser endomicroscopy (pCLE)
- Where
- 9 sites in United States
- Volunteers
- 99 people
- Sponsor
- Mauna Kea Technologies
Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL)
Thymoglobulin to Prevent Acute Graft vs. Host Disease (GvHD) in Patients With Acute Lymphocytic Leukemia (ALL) or Acute Myelogenous Leukemia (AML) Receiving a Stem Cell Transplant
This study involves the use of a drug called Thymoglobulin, which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection.
- Conditions
- Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Graft vs. Host Disease (GvHD)
- Trial name
- NCT00088543
- Testing
- Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)]
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Genzyme, a Sanofi Company
Related Donors Donating PBSC to a Family Member, Healthy Donors
MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies.
- Conditions
- Related Donors Donating PBSC to a Family Member, Healthy Donors, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
- Trial name
- NCT04762875
- Testing
- MGTA-145, Plerixafor
- Where
- 8 sites in United States
- Volunteers
- 7 people
- Sponsor
- Ensoma
Hematologic Malignancies
A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders
To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or…
- Trial name
- HPDSC (NCT00596999)
- Testing
- UCB and HPDSC
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Celgene Corporation
Severe Hepatic Veno-Occlusive Disease
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of…
- Trial name
- NCT00358501
- Testing
- Defibrotide
- Where
- 25 sites in United States, Canada
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT02500550
- Testing
- ATIR101, Haploidentical hematopoietic stem cell transplantation (HSCT), TBI regime
- Where
- 11 sites in Belgium, Canada and 4 more
- Volunteers
- 15 people
- Sponsor
- Kiadis Pharma