Clinical trials: Stem Cell Transplant Complications
Hypospadias
Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure
The purpose of this trial is to assess the safety and efficacy of Holour in patients suffering from hypospadias treatment failure.
- Trial name
- HOLOUR (NCT05093166)
- Testing
- "Ex vivo" expanded autologous human oral epithelium containing stem cells
- Where
- Italy
- Volunteers
- 1 people
- Sponsor
- Holostem s.r.l.
Fungal Infection, Bacterial Infection
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or…
- Trial name
- NCT00430469
- Testing
- human lactoferrin (hLF1-11)
- Where
- Netherlands
- Sponsor
- AM-Pharma
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
Kidney Failure
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
- Trial name
- NCT00497926
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Talaris Therapeutics Inc.
Renal Failure
Induction of Donor Specific Tolerance in Recipients of Live Donor Kidney Allografts by Donor Stem Cell Infusion
The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with kidney failure allowing a reduction or cessation of immune-suppressive therapy.
- Trial name
- NCT00498160
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Talaris Therapeutics Inc.
RSV Infection, Stem Cell Transplant Complications
Study of RV521 in the Treatment of Adult Subjects Who Have Undergone HCT With an URTI With RSV
RV521 is to being developed to treat RSV infection and disease in susceptible individuals at high risk for complications. This is an international, multicenter, placebo-controlled study.
- Conditions
- RSV Infection, Stem Cell Transplant Complications, Lower Resp Tract Infection
- Trial name
- REVIRAL2 (NCT04267822)
- Testing
- RV521 oral tablet
- Sponsor
- Pfizer
Renal Failure
Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use)
Four subjects were treated under compassionate use provisions under this study with facilitating cell therapy (FCRx)
- Trial name
- NCT02051673
- Testing
- Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion
- Where
- United States
- Sponsor
- Talaris Therapeutics Inc.
Hematopoietic Stem Cell Transplantation, Bacterial Infections and Mycoses
Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients
The safety and tolerability of hLF 1-11 has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal disease.
- Trial name
- NCT00509938
- Testing
- human lactoferrin peptide 1-11
- Where
- Netherlands
- Volunteers
- 8 people
- Sponsor
- AM-Pharma
Premature Ovarian Failure，
Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40.
- Trial name
- NCT01742533
- Testing
- human umbilical cord mesenchymal stem cells, hUCMSCs and hCBMNCs, human cord blood mononuclear cells
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Kidney Transplant Rejection
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03606746
- Testing
- MDR-103
- Sponsor
- Medeor Therapeutics, Inc.
Transplant Complication
Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT…
- Trial name
- NCT05762211
- Testing
- Pooled allogeneic fecal microbiotherapy
- Where
- 54 sites in Belgium, France and 4 more
- Volunteers
- 387 people
- Sponsor
- MaaT Pharma
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
Infectious Complications Following HSCT
Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT
DESIGN: Disease registry - non-interventional. INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.
- Trial name
- EPROS (NCT02873325)
- Testing
- antiviral therapies for CMV and/or ADV
- Where
- 2 sites in United Kingdom
- Volunteers
- 1 people
- Sponsor
- Cell Medica Ltd
Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and…
- Trial name
- NCT06665100
- Testing
- PUL-042
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Pulmotect, Inc.
Sickle Cell Disease
Study of Safety and Efficacy of Genome-edited Hematopoietic Stem and Progenitor Cells in Sickle Cell Disease (SCD)
This study evaluated a genome-edited, autologous, hematopoietic stem and progenitor cell (HSPC) product - OTQ923 to reduce the biologic activity of BCL11A, increasing fetal hemoglobin (HbF) and reducing complications of sickle…
- Trial name
- NCT04443907
- Testing
- OTQ923
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Myeloma
WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation
The purpose of this trial is to assess the immune response after vaccination with a peptide vaccine called galinpepimut-S (or GPS) in a type of blood cancer called multiple myeloma.
- Trial name
- NCT01827137
- Testing
- Galinpepimut-S, GM-CSF, Montanide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Sellas Life Sciences Group
Fanconi Anemia Complementation Group A, Fanconi Anemia
Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy
This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial.
- Trial name
- NCT04437771
- Testing
- Safety and efficacy assessments
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Hemorrhagic Cystitis
Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation
The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem…
- Trial name
- NCT07638332
- Testing
- LB-DTK-BKV, Standard-of-care
- Where
- 9 sites in South Korea
- Volunteers
- 42 people
- Sponsor
- LucasBio
Stem Cell Transplant Complications, Thrombotic Microangiopathies
Study in Adult and Pediatric Patients With HSCT-TMA
This is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who were not treated with complement…
- Trial name
- NCT04970004
- Testing
- No intervention
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic
A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
Primary Objective: The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.
- Conditions
- Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic, Stem Cell Transplant Complications
- Trial name
- BOSTON-4 (NCT04107675)
- Testing
- Liposomal Cyclosporine A
- Where
- 17 sites in France, Germany and 1 more
- Volunteers
- 6 people
- Sponsor
- Zambon SpA