Safety and Feasibility of Cultivated Autologous Limbal Stem Cells (cLSC) for Limbal Stem Cell Deficiency
This phase I study will collect preliminary information on the activity and safety of cLSC. We will investigate the ability to manufacture and transplant cLSC onto the cornea successfully at the time of surgery (feasibility), and have cLSC begin to populate the ocular surface (efficacy) without serious adverse events (safety).
NCT03957954 — Limbal Stem-cell Deficiency
Status: Recruiting
http://inclinicaltrials.com/limbal-stem-cell-deficiency/NCT03957954/
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism: An Open Label Controlled Clinical Trial
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism children
NCT03225651 — Stem Cell Transplantation
Status: Completed
http://inclinicaltrials.com/stem-cell-transplantation/NCT03225651/
A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With 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. It has important physical and psychological consequences/impact in those patients. Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.
NCT01742533 — Premature Ovarian Failure,
Status: Recruiting
http://inclinicaltrials.com/premature-ovarian-failure/NCT01742533/
Innovative Osteoarthritis Therapy Using Combination of Mesenchymal Stem Cell (MSC) and Conditioned Medium (CM): A Comparative Study on Arthroscopy and Non-Arthroscopy
This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
NCT04314661 — Osteoarthritis, Knee
Status: Recruiting
http://inclinicaltrials.com/osteoarthritis-knee/NCT04314661/
Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study
The purpose of this study is to assess the efficacy of autologous PBSCT versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) for inflammatory MS failing alternate approved therapy. Disease progression, defined as a 1-point increase in the Expanded Disability Status scale (EDSS) on consecutive evaluations at least 6 months apart and not due to a non-MS disease process. Patients will be followed for 5 years after randomization.
NCT03133403 — Multiple Sclerosis
Status: Recruiting
http://inclinicaltrials.com/multiple-sclerosis/NCT03133403/
Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study
Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 — Multiple Sclerosis
Status: Completed
http://inclinicaltrials.com/multiple-sclerosis/NCT00273364/
Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: - CIML NK cells intravenous infusion (cellular therapy) - Subcutaneous Interleukin-2 (recombinant, human glycoprotein)
NCT06138587 — Leukemia
Status: Recruiting
http://inclinicaltrials.com/leukemia/NCT06138587/
A Phase 1 Clinical Trial of Personalized, Adoptive Cellular Immunotherapy Targeting Patient-specific Neoplastic Stem Cell Neoantigens (PACTN) in Patients With Myelodysplastic Syndromes (MDS)
This study will evaluate the safety of autologous T cells that have been immunized ex vivo with patient-specific MDS stem cell neoantigens in patients with MDS.
NCT03258359 — Myelodysplastic Syndromes
Status: Active, not recruiting
http://inclinicaltrials.com/myelodysplastic-syndromes/NCT03258359/
CMV Specific T Cell Therapy for the Treatment of Relapsing or Therapy Refractory CMV Infection After Allogeneic Stem Cell Transplantation With a CMV-positive Donor.
Viral infections remain an important cause of morbidity and mortality after allogeneic stem cell transplantation (SCT), especially after myelo-ablative conditioning and if the donor is antigen-mismatched or haplo-identical.. In the described setting the patient's own immune system has been destroyed by the necessary highly immuno- and myelo-ablative conditioning and all memory against infections has been deleted. Therefore, there is a high risk for several viral infections and other infectious organisms.Both primary viral infections and reactivations can occur, and patients can become refractory to antiviral treatments, or in some cases an adequate antiviral treatment is unavailable or too toxic. In this study, the investigators will target CMV, as refractory CMV infection and disease is accompanied by an extremely high mortality rate and therefore the development of new treatment approaches is required. Despite the available antiviral drugs, a considerable number of patients are facing an insufficient control of CMV reactivation after SCT. Because reconstitution of CMV-specific T cells confer protection against the development of CMV disease after SCT, attempts have been made to restore antiviral immunity by direct infusion of CMV-specific T cells. Most clinical cellular immunotherapy protocols for CMV treatment have used CMV-specific cytotoxic CD8+ T-cell lines generated by repetitive in vitro stimulation with CMV antigens with success. Despite the proven efficacy, use of cellular therapy in the clinic has been limited, because the approach is time and labor consuming and requires specialized facility allowing handling of the therapeutic cells according to good manufacturing practice. In addition, no sustained response was seen after adoptive transfer that involved only cytotoxic CD8+ T cells. This phenomenon is supported by the fact that recall responses to latent infections depend on the presence of CD4+ T cells to help cytotoxic CD8+ T cells. An alternative approach for the transfer of T-cell immunity is the isolation of Ag-specific T cells ex vivo from the blood of CMV seropositive donors, based on interferon γ (IFN-γ) secretion of T cells after in vitro stimulation with viral Ag, resulting in a combination of CD4+ T helper and cytotoxic CD8+ CMV specific T cells. Using this strategy, a short-term ex vivo protocol was developed for the isolation of pp65 (CMV immunodominant protein)-specific T cells. Since then, several centers have used this protocol in the clinic, infusing low numbers of pp65-specific T cells, that were able to restore protective T-cell immunity against CMV in a post SCT setting in patients with refractory CMV disease or viremia. For this protocol the investigators have set up and validated this method of CMV-specific T-cell generation in the Ghent University Hospital and the investigators will make it available for other Belgian transplant centers.
NCT03067155 — Hematological Malignancies
Status: Completed
http://inclinicaltrials.com/hematological-malignancies/NCT03067155/
Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease
Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases.
NCT02336646 — Critical Limb Ischemia
Status: Completed
http://inclinicaltrials.com/critical-limb-ischemia/NCT02336646/