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Graft vs Host Disease clinical trials

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NCT ID: NCT01633229 Completed - Clinical trials for Graft-Versus-Host Disease

Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications

Start date: November 14, 2011
Phase: Phase 1
Study type: Interventional

Background: - Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been used to treat other post-transplant complications, like marrow failure or tissue injury. - The National Institutes of Health (NIH) has developed a procedure for collecting and preserving BMSC from volunteer donors. These donors have passed tests to ensure that their cells are healthy enough to be used for treatment. Researchers want to use the collected cells to treat people with GVHD, marrow failure, or tissue injury following stem cell transplants. Objectives: - To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem cell transplants. Eligibility: - Individuals between 18 and 75 years of age who have complications from stem cell transplants. - Complications are acute GVHD, poor bone marrow function, or tissue or organ damage. Design: - Participants will be screened with a physical exam and medical history. They will also have imaging studies and blood tests. - Participants will provide blood, skin, and bone marrow samples before the BMSC treatment. Additional samples, including tissue samples, will be collected after the start of treatment. - Participants will have up to three BMSC infusions. There will be a week between each infusion. Participants will be monitored closely during each infusion. Any side effects will be treated. - Treatment will be monitored with frequent blood tests and physical exams. - After the end of the infusions, participants will have regular followup visits for up to 2 years.

NCT ID: NCT01616056 Completed - Clinical trials for Graft Versus Host Disease

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.

NCT ID: NCT01596218 Completed - Clinical trials for Graft vs. Host Disease

Brentuximab Vedotin for Steroid Refractory GvHD

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved brentuximab vedotin for the treatment of GVHD. Currently, corticosteroids are the standard/first line of treatment for people with GVHD. However, some patients do not achieve a good response with steroids and other experience flare-ups while tapering steroid treatment. Corticosteroid treatment has also led to a weakening of the immune system. For this reason, there have been increased attempts by researchers to find other options for the treatment of Graft vs. Host Disease. Brentuximab vedotin is a drug that is FDA approved for the treatment of certain types of cancers, like Hodgkin's lymphoma. Recent research studies have found increased levels of protein called CD30 in people with acute GVHD. Brentuximab vedotin is designed to target CD30. Researchers have never tried to target the CD30 molecule for the treatment of GVHD, but results from other research studies show that it could help slow the growth of your disease. In this research study, we are trying to determine the safest dose of brentuximab vedotin that can be given to patients with GVHD.

NCT ID: NCT01557517 Completed - Clinical trials for Oral Chronic Graft vs Host Disease

Clobetasol for Oral Graft-Versus-Host Disease

Start date: January 26, 2012
Phase: Phase 2
Study type: Interventional

Background: - Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow transplants. It is the result of the donor cells trying to attack the recipients body. Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors, and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can cause side effects when given as pills or injections. Steroids given in a cream or rinse form, applied directly to the site of the symptoms, can have fewer side effects. However, their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD. Objectives: - To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host disease. Eligibility: - Individuals at least 12 years of age who have oral GHVD and are not allergic to clobetasol. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and other tests before starting the study drug. - Participants will be separated into two groups. One group will receive clobetasol; the other will have a placebo liquid. - Participants will rinse their mouths with the study liquid three times a day after meals for 2 weeks. - After 2 weeks, participants will have another study visit with blood tests and other exams. - After the study visit, all participants will start to use the clobetasol rinse. Those who originally had clobetasol will use the rinse for another 2 weeks. Those who originally had a placebo will use the rinse for 4 weeks. - Participants will have a follow-up exam after the end of treatment....

NCT ID: NCT01523821 Completed - Clinical trials for Graft-Versus-Host Disease (GVHD) Acute on Chronic

Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)

Start date: October 11, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.

NCT ID: NCT01520623 Completed - Clinical trials for Allografted With Myeloablative Conditioning

Complement and Graft-versus-host Disease

Start date: April 2010
Phase: N/A
Study type: Interventional

Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT, called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD) in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD without affecting the GvL effect. According to GVHD experimental models, it is likely that GvL but not GvHD may occur in the absence of inflammatory signals induced by the transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system is a major actor of inflammation and in the generation of tissue destruction, both of which are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive or curative manner in such patients. Preliminary data obtained from 34 allografted patients in our institution suggest that Complement activation by the classical pathway is correlated to the occurrence of GI GVHD. The goal of our current project, in order to confirm these preliminary results in a larger series, is to explore Complement system activation in patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two years and to correlate the biological results to the clinical events occurring after HSCT.

NCT ID: NCT01512498 Completed - Clinical trials for Graft-vs-Host Disease

Vulvovaginal Graft Versus Host Disease (VV-GVHD) in Women Who Underwent Transplantation Before and After Menarche

Start date: December 2012
Phase:
Study type: Observational

The study will evaluate the prevalence and characteristics of vulvovaginal graft versus host disease (VV- GVHD) in patients who underwent hematopoietic stem cell transplantation (HSCT) as girls or adolescents and will compare the prevalence, characteristics and severity of VV-GVHD before and after menarche.

NCT ID: NCT01509560 Completed - Clinical trials for Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)

PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood

Start date: November 1, 2011
Phase: Phase 2
Study type: Interventional

In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate.

NCT ID: NCT01491958 Completed - Clinical trials for Myelodysplastic Syndrome

Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

Start date: December 10, 2011
Phase: Phase 2
Study type: Interventional

Phase II trial evaluating the safety & efficacy of Atorvastatin for prophylaxis of Acute Graft Versus Host Disease (GVHD) in patients with hematological malignances undergoing human leukocyte antigen (HLA)-Matched Related Donor Hematopoietic Stem Cell Transplant (HSCT).

NCT ID: NCT01463475 Completed - Clinical trials for Acute Myocardial Infarction (AMI)

University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

Start date: September 2011
Phase: N/A
Study type: Interventional

The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.