Please use this listing for your research, but continue to speak to your treating Australian doctors for independent advice on what is best for you.
It is important to remember that just because a treatment is being evaluated as part of a clinical trial, that does not make it a proven safe and effective therapy. These trials are experimental. All clinical trials, however, must gain full ethical approval from a registered regulatory body. When searching for clinical trials, ensure you check it has ethical approval before registering. 

The listed trials have been sourced from the Australian clinical trials registry, the 
ANZCTR. This website remains the best place to obtain the most up to date information on clinical trials.

tagged as Registered Clinical Trials In Australia

  • I-ACT: Phase I trial of Amnion Cell Therapy for Ischaemic Stroke to establish the maximum tolerable dose Location: Australia
    Overview:
    This trial is a dose escalation study to determine the maximal tolerable dose of human amnion stem cell for the treatment of acute ischaemic stroke (focal brain ischaemia from blood clot obstructing the vessel lumen).

    Condition: Ischaemic stroke
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Not Recruiting
    Stem Cell: Amniotic Tissue Stem Cells
  • Stem Cells in Umbilical Blood Infusion for Cerebral Palsy Location: Australia
    Overview: Cerebral palsy (CP) is the most common physical disability of childhood, affecting 2 per 1000 live births across the world. CP describes permanent non-progressive motor disorders arising from damage to the developing brain. CP is often associated with epilepsy, difficulties in speech, sight, hearing, sensation, perception, behaviour or cognition. There is no cure for CP.

    Preclinical studies of different types of stem cells in models of acute brain injury similar to CP have shown significant functional improvement. The variety of stem cells available in umbilical cord blood (UCB), an ethically uncomplicated source of stem cells, has led to a focus on UCB stem cell therapy as a quick-to-clinic option. Previous studies indicate that autologous or unrelated donor UCBC infusion is safe and feasible for children with CP, and may lead to improved motor functioning, but there is no information about the safety and effects of matched sibling cord blood available.

    Therefore, this trial will study the safety of infusing matched sibling cord blood cells to children with cerebral palsy. Additionally, we will assess how long the cells remain within the recipient through sensitive chimerism assays, as we hypothesise that the cells may be rejected within 24 hours of infusion. Finally, we will trial the use of a range of outcome measures in this context.

    Condition: Cerebral Palsy
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Not Recruiting
    Stem Cell: Umbilical Cord Stem Cells
  • A pilot study evaluating the safety of intravenously administered human amnion epithelial cells for the treatment of hepatic fibrosis Location: Australia
    Overview:
    We propose a first-in-man clinical trial of human amnion epithelial cells (hAEC), a type of stem cell obtained from the placenta, The placenta is normally discarded after delivery so the use of hAEC does not pose any ethical issues. In laboratory studies we have shown that these cells can reduce liver fibrosis (scar tissue in the liver) and stimulate regeneration of liver cells.. Worldwide, cirrhosis is the sixth most common cause of death and liver transplantation remains the only chance for survival for some people with cirrhosis. In this study we will assess the safety and tolerability of giving hAEC to patients with stable liver cirrhosis. Our long-term goal is to develop hAEC as a clinically useful therapy to reduce the need for liver transplantation.

    Condition: Cirrhosis
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Not Recruiting
    Stem Cell: Amniotic Tissue Stem Cells
  • A Phase II study: Haematopoietic Stem Cell Transplantation for highly active treatment resistant multiple sclerosis . Location: Australia
    Overview:
    Over the past 15 years a number of new treatments have proved successful in the treatment of multiple sclerosis. There a remains though a small group of patients who do not respond and who continue to have attacks despite treatment causing further permanent neurological disability in a cumulative fashion. This disability can take the form of muscle weakness, impairing walking ability, visual loss, impaired balance, bladder and bowel dysfunction and loss of higher intellectual faculties. Patients with aggressive forms of MS also have a shortened life span as a result of their disease.

    Haematopoietic stem cell transplantation (HSCT) is a procedure originally used to treat patients with blood cancers. A high dose of chemotherapy is given which not only kills the malignant cells but also normal healthy bone marrow and blood cells. In order for the patient to survive these cells must be replaced by giving the patient a stem cell infusion following the chemotherapy . The stem cells replenish the bone marrow and a new blood and immune system then grows from it. 
    Over the last 15 years, HSCT has become much safer. At the same time, numerous lines of evidence have emerged suggesting that a small number of patients with severe autoimmune diseases such as MS not controlled by other treatments could also respond to treatment with HSCT. This evidence came initially from patients with a co-existent auto-immune disease (AID) including multiple sclerosis (MS) who had chemotherapy for blood tumours. It was observed that not only did their cancers remain in prolonged remission after HSCT but so did the manifestations of their autoimmune disease. 

    The procedure requires an initial dose of chemotherapy with a drug called cyclophosphamide to help stem cells to be collected via a vein in the arm. Subsequently the patient is admitted into hospital tohave high doses of chemotherapy that intensely suppresses the immune system. At this point the stem cells collected at the earlier time point are reinfused through the vein so they can re-grow a new immune system and protect the patient from the toxic effects of the chemotherapy. It takes about 14 days for the new stem cells to grow and then follow up is conducted carefully over several years to see if this method of immunosuppression and immune reconstitution prevents the reemergence of multiple sclerosis. The procedure is not without risk with the major complications of infection and death. Overall the risk of death where the procedure is done for an autoimmune disease is quoted at between 1-5 %.

    The Neurology Unit at Austin Health has conducted trials in MS since 1996 and the Haematology Unit performs HSCT on a regular basis for patients with blood malignancies. The unit’s morbidity and mortality results for HSCT are on par with the world’s leading hospitals. We intend to explore therapy in patients with an aggressive form of MS and then follow them in a rigorous fashion over 5 years to gauge its effectiveness.

    Condition: Multiple Sclerosis
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Mesenchymal Stem Cells (MSC) for the amelioration of ischaemia-reperfusion injury (IRI) after deceased donor renal transplantation, a phase 1 pilot study Location: Australia
    Overview:
    In performing a renal transplant, the time spent by the graft outside the body and cooled on ice (non-perfused) is critical to its future functional capacity. With deceased donor transplants, this may be many hours and there is damage caused to the cells of the kidney by the lack of oxygenated bood suppy, which is called ischaemia. On connection of the donor renal atery to the intended recipients leg artery, blood flow is suddenly restored and the kidney is rewarmed or reperfused. Reperfusion itself is associated with further damage caused by the complex changes on blood vessels and immunological response following the period of ischaemia; the ischaemia-reperfusion injury (IRI). This may lead to delayed function of the kidney, during which the kidney undegoes repair. Changes associated with its recovery may include those that cause injury and scarring and lead to significantly worse renal function in the longer term, causing premature graft senescence and loss. There are currently few effective strategies to reduce this damaging response other than minimsation of cold ischaemia time. Many animal studies have shown that the infusion of mesenchymal stromal cells (MSC) to the recipient lessens the injury associated with IRI and allows earlier short term and better long term kidney function.

    We propose to use third party normal (non-immunogenic) MSC at the time of and 7 days following reperfusion of a cold stored kidney, in order to lessen this damage in a pilot study of 10 patients. 

    Condition: Ischaemia Reperfusion Injury
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Stem Cells (unspecified)
  • A Phase I Study to Evaluate the Safety and Efficacy of Mesenchymal Stromal Cells (MSC) for Treating Chronic Obstructive Pulmonary Disease (COPD) Location: Australia
    Overview:
    This is a safety study looking at the role of mesenchymal stem cells (MSCs) in the treatment of Chronic Pulmonary Pulmonary Disease (COPD). We will give COPD patients 2 infusions of MSCs. The first infusion will have labelled MSCs with Indium. Following the infusion, MSCs will be tracked using nuclear medicine imaging for 5 days. Thereafter, there will be a second infusion of unlabelled MSCs. Patients will be then followed up at clinics with particular assessment of symptoms, quality of life, lung function and imrpoved well being. 

    Condition: COPD
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Recruiting
    Stem Cell: Adult Fatty Tissue Stem Cells
  • Phase III Clinical Study of Allogeneic Stem Cell Transplantation with Reduced Conditioning (RICT) versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission Location: Australia
    Overview:
    This study assesses if patients who are suitable for a transplant (and have a suitable bone marrow donor) will have better results if they are treated with a transplant compared to those patients that would have had a transplant but a suitable bone marrow donor was not available and instead received standard chemotherapy. The trial results will show whether future treatment of AML in patients over 50 should always include BMT whenever possible.

    Condition: Leukaemia
    Link to Clinical Registry
    Trial Design: Therapeutic intervention
    Status: Open - Not Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Haploidentical stem cell transplantation with iCasp9 T cell addback in patients with poor risk haematological malignancies Location: Australia
    Overview:
    This study is evaluating the safety of haploidentical stem cell transplantation using high dose chemotherapy and radiotherapy, with the infusion of donor stem cells followed by the infusion of genetically modified donor T cells. The genetic modification involves the insertion of a safety switch, called iCasp9, into the donor T cells, which allows the cells to be removed with a drug, AP1903, if the patient develops graft-versus-host disease, which is a life-threatening complication of stem cell transplantation.

    Condition: Leukaemia
    Link to Clinical Registry
    Trial Design: Observational Study
    Status: Open - Recruiting
    Stem Cell: Adult Bone Marrow Stem Cells
  • Amnion cells for the treatment of bronchopulmonary dysplasia in premature babies Location: Australia
    Overview:
    In Australia, about one in twelve babies are born prematurely. Compared to those born at term gestation these babies, particularly those born very or extremely preterm, are at increased risk of life-threatening conditions such as bronchopulmonary dysplasia. This condition represents a major challenge because, not only is it life-threatening, but also there is no specific directed treatment. Current management is essentially limited to supportive care. As such, the mortality and morbidity toll exacted by bronchopulmonary dysplasia remains challenging, to say the least.

    We have recently shown that stem-like cells can be isolated from the amniotic membrane. These cells, term human amnion epithelial cells (hAECs), bear many characteristics of traditional stem cells such as pluripotency, ability to self-renew and are able to escape immune surveillance, thus avoiding immune rejection even when administered xenogeneically. In our preclinical studies, we showed that hAECs were able to prevent and rescue lung injury in animal models of adult and neonatal lung disease.

    In this clinical trial, we aim to evaluate the safety of hAECs delivered intravenously to preterm babies with established bronchopulmonary dysplasia. 

    Condition: Bronchopulmonary Dysplasia
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Open - Recruiting
    Stem Cell: Amniotic Tissue Stem Cells
  • A Single Centre Phase II Study Of Haematopoietic Stem Cell Transplantation (HSCT) for Severe Auto-Immune Diseases. Location: Australia
    Overview:
    Diseases such as Scleroderma, Multiple Sclerosis (MS), Systemic Lupus Erythematosus (SLE), vasculitis, Chrohn’s disease, Behcet’s disease refractory to all available therapies and in the opinion of the referring physician, HSCT is a valid therapeutic option for that patient. These patients will require an independent physician to assess the patient’s suitability for HSCT. Patients will undergo GSCF stimulated stem cell collection following chemotherapy. Patients are readmitted for autlogous transplant and will have specific high dose immunosuppresssive therapy depending on their disorder followed by stem cell re infusion

    Condition: Autoimmune Diseases
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Recruiting
    Stem Cell: Stem Cells (unspecified)
  • Human Amnion Epithelial Cells for Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Safety Study Location: Australia
    Overview: Owing to advances in neonatal care, survival of preterm infants, particularly those born at less than or equal to 28 weeks, is increasing. Survival brings with it the risk of morbidity. Bronchopulmonary dysplasia (BPD), lung disease unique to preterm infants, is an important morbidity associated with long term impairments of lung function and neurodevelopment. Despite advances in the care of preterm infants, rates of BPD in survivors have not changed over recent decades. In fact, pulmonary outcomes in recent cohorts of preterm infants appear worse.

    With developments in neonatal medicine over the last few decades the phenotype of BPD has changed. Today, infants at greatest risk of BPD are born in the canalicular phase of lung development, a time when alveolar and distal capillary development commences. Preterm delivery and the interventions compromising neonatal intensive care create a proinflammatory environment disrupting the architecture of vulnerable developing lungs. Targeting inflammation with new generation therapies may provide new therapeutic options for BPD. Preclinical models have demonstrated human amnion epithelial cells (hAECs) can prevent and repair lung injury by modifying the inflammatory response, helping to restore normal lung architecture. hAECs have potential to reduce the incidence and/or severity of BPD.
    A small phase 1 study completed at Monash Health in Melbourne, Australia gave 1 million hAECs/kg to infants with established BPD. This was a first-in-human study and appropriately gave a conservative dose of hAECs to assess safety. Prior to larger trials to study the efficacy of hAECs as a preventive therapy for BPD, tolerance to higher doses of hAECs, which are more likely to be efficacious based on preclinical studies, must be established in a younger, less mature population of preterm infants. 

    Accordingly, we propose a multicentre dose escalation trial to assess the safety of intravenously administered hAECs in preterm infants at high risk of developing BPD. Infants will be assessed as being at high risk of BPD if delivered at less than 29 weeks gestational age and on Day 14 of life require either mechanical ventilation with an FiO2 greater than or equal to 0.25 or non-invasive respiratory support with an FiO2 greater than or equal to 0.35. 
    24 infants will be recruited and given intravenous hAECs during the third and fourth week of life at doses increasing from 2 million hAECs/kg to 30 million hAECs/kg. The first 12 infants will receive a single infusion to a maximum dose of 10 million hAECs/kg. Larger total doses will be achieved in the final 12 patients by repeat infusions at 5 day intervals.

    Safety is the primary outcome and will be defined by the occurrence of adverse events during the 2 year follow-up period. Secondary outcomes include cytokine profiling and neonatal morbidities, in particular the incidence and severity of BPD.

    Condition: Bronchopulmonary Dysplasia
    Link to Clinical Registry
    Trial Design: Safety Study
    Status: Not yet started
    Stem Cell: Amniotic Tissue Stem Cells
  • Orthotopic heart transplantation followed by autologous stem cell transplantation in patients with cardiac AL amyloidosis - a pilot study Location: Australia
    Overview:
    This study aims to investigate the safety and efficacy of autologous stem cell transplantation in AL amyloid patients with advanced cardiac disease. 
    after a orthotopic heart transplantation. 

    You may be eligible to join this study if you are aged between 18-65 years and have been diagnosed with cardiac AL amyloidosis. 

    All participants in this study are required to have previously received chemotherapy and a orthotopic heart transplantation before being enrolled in the study to received an autologous stem cell transplantation. Patients will undergo autologous stem cell transplantation (ASCT) within 3-6 months after OHT. 

    Patients will have an Autologous stem cell transplant using Melphalan 200mg/m2 on day -1 with stem cell collected given on day 0 previously from the patient before the study. 

    All participants will be followed up every 3 to 6 months for a period of 5 years, in order to assess survival, and safety and efficacy of treatment.

    This pilot study will determine if treating patient with a stem cell transplant with cardiac amyloid after receiving a heart transplant will increase disease free survival

    Condition: Cardiac Amyloidosis
    Link to Clinical Registry
    Trial Design: Safety and Efficacy Study
    Status: Open - Not Recruiting
    Stem Cell: Stem Cells (unspecified)