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Article ; Online: CAR-T cell development for Cutaneous T cell Lymphoma: current limitations and potential treatment strategies.

To, Van / Evtimov, Vera J / Jenkin, Graham / Pupovac, Aleta / Trounson, Alan O / Boyd, Richard L

2022 Volume 13, Page(s) 968395

Abstract: Chimeric antigen receptor (CAR)-T therapy has demonstrated remarkable outcomes for B cell malignancies, however, its application for T cell lymphoma, particularly cutaneous T cell lymphoma (CTCL), has been limited. Barriers to effective CAR-T cell ... ...

Abstract	Chimeric antigen receptor (CAR)-T therapy has demonstrated remarkable outcomes for B cell malignancies, however, its application for T cell lymphoma, particularly cutaneous T cell lymphoma (CTCL), has been limited. Barriers to effective CAR-T cell therapy in treating CTCL include T cell aplasia in autologous transplants, CAR-T product contamination with leukemic T cells, CAR-T fratricide (when the target antigen is present on normal T cells), and tumor heterogeneity. To address these critical challenges, innovative CAR engineering by targeting multiple antigens to strike a balance between efficacy and safety of the therapy is necessary. In this review, we discuss the current obstacles to CAR-T cell therapy and highlight potential targets in treating CTCL. Looking forward, we propose strategies to develop more powerful dual CARs that are advancing towards the clinic in CTCL therapy.
MeSH term(s)	Humans ; Immunotherapy, Adoptive/adverse effects ; Lymphoma, T-Cell, Cutaneous/therapy ; Receptors, Chimeric Antigen/genetics ; Skin Neoplasms/therapy ; T-Lymphocytes
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2022-08-18
Publishing country	Switzerland
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2022.968395
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Article ; Online: Umbilical Cord Blood and Cord Tissue-Derived Cell Therapies for Neonatal Morbidities: Current Status and Future Challenges.

Zhou, Lindsay / McDonald, Courtney / Yawno, Tamara / Jenkin, Graham / Miller, Suzanne / Malhotra, Atul

Stem cells translational medicine

2022 Volume 11, Issue 2, Page(s) 135–145

Abstract: Cell therapies are an emerging focus for neonatal research, with benefits documented for neonatal respiratory, neurological, and cardiac conditions in pre-clinical studies. Umbilical cord blood (UCB) and umbilical cord (UC) tissue-derived cell therapy is ...

Abstract	Cell therapies are an emerging focus for neonatal research, with benefits documented for neonatal respiratory, neurological, and cardiac conditions in pre-clinical studies. Umbilical cord blood (UCB) and umbilical cord (UC) tissue-derived cell therapy is particularly appealing for preventative or regenerative treatment of neonatal morbidities; they are a resource that can be collected at birth and used as an autologous or allogeneic therapy. Moreover, UCB contains a diverse mix of stem and progenitor cells that demonstrate paracrine actions to mitigate damaging inflammatory, immune, oxidative stress, and cell death pathways in several organ systems. In the past decade, published results from early-phase clinical studies have explored the use of these cells as a therapeutic intervention in neonates. We present a systematic review of published and registered clinical trials of UCB and cord tissue-derived cell therapies for neonatal morbidities. This search yielded 12 completed clinical studies: 7 were open-label phase I and II safety and feasibility trials, 3 were open-label dose-escalation trials, 1 was a open-label placebo-controlled trial, and 1 was a phase II randomized controlled trial. Participants totaled 206 infants worldwide; 123 (60%) were full-term infants and 83 (40%) were preterm. A majority (64.5%) received cells via an intravenous route; however, 54 (26.2%) received cells via intratracheal administration, 10 (4.8%) intraoperative cardiac injection, and 9 (4.3%) by direct intraventricular (brain) injection. Assessment of efficacy to date is limited given completed studies have principally been phase I and II safety studies. A further 24 trials investigating UCB and UC-derived cell therapies in neonates are currently registered.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Fetal Blood ; Hematopoietic Stem Cell Transplantation ; Humans ; Infant, Newborn ; Morbidity ; Randomized Controlled Trials as Topic ; Transplantation, Autologous/methods ; Umbilical Cord
Language	English
Publishing date	2022-03-09
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2642270-0
ISSN	2157-6580 ; 2157-6580
ISSN (online)	2157-6580
ISSN	2157-6580
DOI	10.1093/stcltm/szab024
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Article ; Online: Feasibility of cord blood collection for autologous cell therapy applications in extremely preterm infants.

Zhou, Lindsay / McDonald, Courtney A / Yawno, Tamara / Penny, Tayla / Miller, Suzanne L / Jenkin, Graham / Malhotra, Atul

Cytotherapy

2023 Volume 25, Issue 5, Page(s) 458–462

Abstract: Background aims: Umbilical cord blood (UCB)-derived cells show strong promise as a treatment for neonatal brain injury in pre-clinical models and early-phase clinical trials. Feasibility of UCB collection and autologous administration is reported for ... ...

Abstract	Background aims: Umbilical cord blood (UCB)-derived cells show strong promise as a treatment for neonatal brain injury in pre-clinical models and early-phase clinical trials. Feasibility of UCB collection and autologous administration is reported for term infants, but data are limited for preterm infants. Here the authors assessed the feasibility of UCB-derived cell collection for autologous use in extremely preterm infants born at less than 28 weeks, a population with a high incidence of brain injury and subsequent neurodisability. Methods: In a prospective study at a tertiary hospital in Melbourne, Australia, UCB was collected from infants born at less than 28 weeks and processed to obtain total nucleated cells (TNCs), CD34+ cells, mononuclear cells and cell viability via fluorescence-activated cell sorting prior to cryopreservation. Feasibility was pre-defined as volume adequate for cryopreservation (>9 mL UCB collected) and >25 × 10 Results: Thirty-eight infants (21 male, 17 female) were included in the study. Twenty-four (63.1%) were delivered via cesarean section, 30 (78.9%) received delayed cord clamping before collection and 11 (28.9%) were a multiple birth. Median (interquartile range [IQR]) gestational age was 26.0 weeks (24.5-27.5) and mean (standard deviation) birth weight was 761.5 g (221.5). Median (IQR) UCB volume collected was 19.1 mL/kg (10.5-23.5), median (IQR) TNC count was 105.2 × 10 Conclusions: UCB-derived cell collection adequate for cryopreservation and subsequent autologous reinfusion was achieved in 70% of extremely preterm infants. Extremely preterm UCB demonstrated a higher CD34+:TNC ratio compared with published full-term values. Recruitment to demonstrate safety of UCB cell administration in extremely premature infants is ongoing in the CORD-SAFE study (trial registration no. ACTRN12619001637134).
MeSH term(s)	Humans ; Infant, Newborn ; Male ; Pregnancy ; Female ; Infant ; Infant, Extremely Premature ; Fetal Blood ; Cesarean Section ; Prospective Studies ; Feasibility Studies
Language	English
Publishing date	2023-02-04
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2023.01.001
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Article ; Online: Neuroprotective effects of maternal melatonin administration in early-onset placental insufficiency and fetal growth restriction.

Malhotra, Atul / Rocha, Anna K A A / Yawno, Tamara / Sutherland, Amy E / Allison, Beth J / Nitsos, Ilias / Pham, Yen / Jenkin, Graham / Castillo-Melendez, Margie / Miller, Suzanne L

Pediatric research

2024

Abstract: Background: Early-onset fetal growth restriction (FGR) is associated with adverse outcomes. We hypothesised that maternal melatonin administration will improve fetal brain structure in FGR.: Methods: Surgery was performed on twin-bearing ewes at 88 ... ...

Abstract	Background: Early-onset fetal growth restriction (FGR) is associated with adverse outcomes. We hypothesised that maternal melatonin administration will improve fetal brain structure in FGR. Methods: Surgery was performed on twin-bearing ewes at 88 days (0.6 gestation), and FGR induced in one twin via single umbilical artery ligation. Melatonin was administered intravenously (6 mg/day) to a group of ewes commencing on day of surgery until 127 days (0.85 gestation), when the ewe/fetuses were euthanized, and fetal brains collected. Results: Study groups were control (n = 5), FGR (n = 5), control+melatonin (control+MLT; n = 6) and FGR+melatonin (FGR + MLT; n = 6). Melatonin administration did not significantly alter fetal body or brain weights. Myelin (CNPase+) fibre density was reduced in FGR vs. control animals in most brain regions examined (p < 0.05) and melatonin treatment restored CNPase fibre density. Similar but less pronounced effect was seen with mature myelin (MBP+) staining. Significant differences in activated microglia (Iba-1) activity were seen between lamb groups (MLT mitigated FGR effect) in periventricular white matter, subventricular zone and external capsule (p < 0.05). Similar effects were seen in astrogliosis (GFAP) in intragyral white matter and cortex. Conclusions: Maternal melatonin administration in early onset FGR led to improved myelination of white matter brain regions, possibly mediated by decreased inflammation. Impact: Maternal melatonin administration might lead to neuroprotection in the growth-restricted fetus, possibly via dampening neuroinflammation and enhancing myelination. This preclinical study adds to the body of work on this topic, and informs clinical translation. Neuroprotection likely to improve long-term outcomes of this vulnerable infant group.
Language	English
Publishing date	2024-01-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	4411-8
ISSN	1530-0447 ; 0031-3998
ISSN (online)	1530-0447
ISSN	0031-3998
DOI	10.1038/s41390-024-03027-4
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Article ; Online: The Temporal Relationship between Blood-Brain Barrier Integrity and Microglial Response following Neonatal Hypoxia Ischemia.

Jithoo, Arya / Penny, Tayla R / Pham, Yen / Sutherland, Amy E / Smith, Madeleine J / Petraki, Maria / Fahey, Michael C / Jenkin, Graham / Malhotra, Atul / Miller, Suzanne L / McDonald, Courtney A

Cells

2024 Volume 13, Issue 8

Abstract: Blood-brain barrier (BBB) dysfunction and neuroinflammation are key mechanisms of brain injury. We performed a time-course study following neonatal hypoxia-ischemia (HI) to characterize these events. HI brain injury was induced in postnatal day 10 rats ... ...

Abstract	Blood-brain barrier (BBB) dysfunction and neuroinflammation are key mechanisms of brain injury. We performed a time-course study following neonatal hypoxia-ischemia (HI) to characterize these events. HI brain injury was induced in postnatal day 10 rats by single carotid artery ligation followed by hypoxia (8% oxygen, 90 min). At 6, 12, 24, and 72 h (h) post-HI, brains were collected to assess neuropathology and BBB dysfunction. A significant breakdown of the BBB was observed in the HI injury group compared to the sham group from 6 h in the cortex and hippocampus (
MeSH term(s)	Animals ; Microglia/pathology ; Microglia/metabolism ; Blood-Brain Barrier/pathology ; Blood-Brain Barrier/metabolism ; Hypoxia-Ischemia, Brain/pathology ; Hypoxia-Ischemia, Brain/metabolism ; Animals, Newborn ; Rats ; Rats, Sprague-Dawley ; Time Factors ; Male ; Female
Language	English
Publishing date	2024-04-09
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells13080660
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Article ; Online: Autologous transplantation of umbilical cord blood-derived cells in extreme preterm infants: protocol for a safety and feasibility study.

Malhotra, Atul / Novak, Iona / Miller, Suzanne Lee / Jenkin, Graham

BMJ open

2020 Volume 10, Issue 5, Page(s) e036065

Abstract: Introduction: Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature infants. Umbilical cord blood-derived cells (UCBCs) are increasingly being evaluated for their neuroprotective and ... ...

Abstract	Introduction: Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature infants. Umbilical cord blood-derived cells (UCBCs) are increasingly being evaluated for their neuroprotective and neuroreparative properties in preclinical and clinical studies. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants. Methods and analysis: A single centre safety and feasibility study in preterm babies born before 28 weeks gestation. Cord blood will be collected after birth and if sufficient blood is obtained, UCB mononuclear cells will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, based on cranial ultrasounds in first week of life, preterm infants will be infused with autologous UCBCs via the intravenous route at a dose of 25-50 million UCBCs/kg body weight of live cells, with the cell number being the maximum available up to 50 million cells/kg. A minimum of 20 infants will be administered autologous UCBCs. Primary outcomes will include feasibility and safety. Feasibility will be determined by access to sufficient cord blood at collection and UCBCs following processing. Safety will be determined by lack of adverse events directly related to autologous UCBC administration in the first few days after cell administration. Secondary outcomes studied will include neonatal and neurodevelopmental morbidities till 2 years of life. Additional outcomes will include cell characteristics of all collected cord blood, and cytokine responses to cell administration in transplanted infants till 36 weeks' corrected age. Ethics and dissemination: Monash Health Human Research Ethics Committee approved this study in December 2019. Recruitment is to commence in July 2020 and is expected to take around 12 months. The findings of this study will be disseminated via peer-reviewed journals and at conferences. Trial registration number: ACTRN12619001637134.
MeSH term(s)	Blood Specimen Collection/methods ; Brain Injuries/prevention & control ; Clinical Protocols ; Cord Blood Stem Cell Transplantation/adverse effects ; Cord Blood Stem Cell Transplantation/methods ; Feasibility Studies ; Fetal Blood/cytology ; Humans ; Infant, Extremely Premature ; Infant, Newborn ; Infusions, Intravenous ; Leukocytes, Mononuclear/transplantation ; Safety ; Transplantation, Autologous/adverse effects ; Transplantation, Autologous/methods
Language	English
Publishing date	2020-05-11
Publishing country	England
Document type	Journal Article
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2019-036065
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Article ; Online: Effect of expansion of human umbilical cord blood CD34 + cells on neurotrophic and angiogenic factor expression and function.

Watt, Ashalyn P / Kirkland, Mark / Nekkanti, Lakshmi / Pham, Yen / McDonald, Courtney / Malhotra, Atul / Moeneclaey, Guy / Miller, Suzanne L / Jenkin, Graham

Cell and tissue research

2022 Volume 388, Issue 1, Page(s) 117–132

Abstract: The use of CD34 + cell-based therapies has largely been focused on haematological conditions. However, there is increasing evidence that umbilical cord blood (UCB) CD34 + -derived cells have neuroregenerative properties. Due to low cell numbers of CD34 + ...

Abstract	The use of CD34 + cell-based therapies has largely been focused on haematological conditions. However, there is increasing evidence that umbilical cord blood (UCB) CD34 + -derived cells have neuroregenerative properties. Due to low cell numbers of CD34 + cells present in UCB, expansion is required to produce sufficient cells for therapeutic purposes, especially in adults or when frequent applications are required. However, it is not known whether expansion of CD34 + cells has an impact on their function and neuroregenerative capacity. We addressed this knowledge gap in this study, via expansion of UCB-derived CD34 + cells using combinations of LDL, UM171 and SR-1 to yield large numbers of cells and then tested their functionality. CD34 + cells expanded for 14 days in media containing UM171 and SR-1 resulted in over 1000-fold expansion. The expanded cells showed an up-regulation of the neurotrophic factor genes BDNF, GDNF, NTF-3 and NTF-4, as well as the angiogenic factors VEGF and ANG. In vitro functionality testing showed that these expanded cells promoted angiogenesis and, in brain glial cells, promoted cell proliferation and reduced production of reactive oxygen species (ROS) during oxidative stress. Collectively, this study showed that our 14-day expansion protocol provided a robust expansion that could produce enough cells for therapeutic purposes. These expanded cells, when tested in in vitro, maintained functionality as demonstrated through promotion of cell proliferation, attenuation of ROS production caused by oxidative stress and promotion of angiogenesis.
MeSH term(s)	Adult ; Angiogenesis Inducing Agents/metabolism ; Antigens, CD34/metabolism ; Cell Proliferation ; Cells, Cultured ; Fetal Blood ; Humans
Chemical Substances	Angiogenesis Inducing Agents ; Antigens, CD34
Language	English
Publishing date	2022-02-02
Publishing country	Germany
Document type	Journal Article
ZDB-ID	125067-x
ISSN	1432-0878 ; 0302-766X
ISSN (online)	1432-0878
ISSN	0302-766X
DOI	10.1007/s00441-022-03592-2
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Article: Phenotype of early-onset fetal growth restriction in sheep.

Sutherland, Amy E / White, Tegan A / Rock, Charmaine R / Piscopo, Beth R / Dudink, Ingrid / Inocencio, Ishmael M / Azman, Zahrah / Pham, Yen / Nitsos, Ilias / Malhotra, Atul / Yawno, Tamara / Polglase, Graeme R / Jenkin, Graham / Camm, Emily J / Allison, Beth J / Miller, Suzanne L

Frontiers in endocrinology

2024 Volume 15, Page(s) 1374897

Abstract: Introduction: Fetal growth restriction (FGR) is a common pregnancy complication, caused by placental insufficiency, with serious adverse consequences for development : Methods: FGR was induced via surgical placental insufficiency in fetal sheep (89 ... ...

Abstract	Introduction: Fetal growth restriction (FGR) is a common pregnancy complication, caused by placental insufficiency, with serious adverse consequences for development Methods: FGR was induced via surgical placental insufficiency in fetal sheep (89 days gestation/0.6 gestation; n=135) and compared to age-matched controls over the last third of gestation and into neonatal life (n=153). Results: Body weight of FGR fetuses/lambs was significantly reduced compared to controls (p<0.0001) from 127 days of gestation (term is 148 days), with increased brain:body weight ratio (p<0.0001) indicative of brain sparing. All biometric measures of body size were reduced in the FGR group with the exception of biparietal (head) diameter. The trajectory of body growth in the last trimester of sheep pregnancy was significantly reduced in the FGR group compared to controls, and stillbirth rate increased with longer gestation. Discussion: This work provides a well characterised FGR animal model that mimics the known physiological adaptations in human pregnancy and can be used to determine the efficacy of potential interventions.
MeSH term(s)	Sheep ; Animals ; Female ; Pregnancy ; Humans ; Fetal Growth Retardation/etiology ; Placental Insufficiency ; Placenta ; Phenotype ; Body Weight
Language	English
Publishing date	2024-03-13
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2592084-4
ISSN	1664-2392
ISSN	1664-2392
DOI	10.3389/fendo.2024.1374897
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Article: Effect of expansion of human umbilical cord blood CD34 + cells on neurotrophic and angiogenic factor expression and function

Watt, Ashalyn P. / Kirkland, Mark / Nekkanti, Lakshmi / Pham, Yen / McDonald, Courtney / Malhotra, Atul / Moeneclaey, Guy / Miller, Suzanne L. / Jenkin, Graham

Cell and tissue research. 2022 Apr., v. 388, no. 1

2022

Abstract	The use of CD34 + cell-based therapies has largely been focused on haematological conditions. However, there is increasing evidence that umbilical cord blood (UCB) CD34 + -derived cells have neuroregenerative properties. Due to low cell numbers of CD34 + cells present in UCB, expansion is required to produce sufficient cells for therapeutic purposes, especially in adults or when frequent applications are required. However, it is not known whether expansion of CD34 + cells has an impact on their function and neuroregenerative capacity. We addressed this knowledge gap in this study, via expansion of UCB-derived CD34 + cells using combinations of LDL, UM171 and SR-1 to yield large numbers of cells and then tested their functionality. CD34 + cells expanded for 14 days in media containing UM171 and SR-1 resulted in over 1000-fold expansion. The expanded cells showed an up-regulation of the neurotrophic factor genes BDNF, GDNF, NTF-3 and NTF-4, as well as the angiogenic factors VEGF and ANG. In vitro functionality testing showed that these expanded cells promoted angiogenesis and, in brain glial cells, promoted cell proliferation and reduced production of reactive oxygen species (ROS) during oxidative stress. Collectively, this study showed that our 14-day expansion protocol provided a robust expansion that could produce enough cells for therapeutic purposes. These expanded cells, when tested in in vitro, maintained functionality as demonstrated through promotion of cell proliferation, attenuation of ROS production caused by oxidative stress and promotion of angiogenesis.
Keywords	angiogenesis ; blood ; brain ; cell proliferation ; humans ; oxidative stress ; reactive oxygen species ; research ; therapeutics ; umbilical cord
Language	English
Dates of publication	2022-04
Size	p. 117-132.
Publishing place	Springer Berlin Heidelberg
Document type	Article
ZDB-ID	125067-x
ISSN	1432-0878 ; 0302-766X
ISSN (online)	1432-0878
ISSN	0302-766X
DOI	10.1007/s00441-022-03592-2
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Article ; Online: Endothelial colony forming cell administration promotes neurovascular unit development in growth restricted and appropriately grown fetal lambs.

Bell, Alexander / Watt, Ashalyn P / Dudink, Ingrid / Pham, Yen / Sutherland, Amy E / Allison, Beth J / McDonald, Courtney A / Castillo-Melendez, Margie / Jenkin, Graham / Malhotra, Atul / Miller, Suzanne L / Yawno, Tamara

Stem cell research & therapy

2023 Volume 14, Issue 1, Page(s) 29

Abstract: Background: Fetal growth restriction (FGR) is associated with deficits in the developing brain, including neurovascular unit (NVU) dysfunction. Endothelial colony forming cells (ECFC) can mediate improved vascular stability, and have demonstrated ... ...

Abstract	Background: Fetal growth restriction (FGR) is associated with deficits in the developing brain, including neurovascular unit (NVU) dysfunction. Endothelial colony forming cells (ECFC) can mediate improved vascular stability, and have demonstrated potential to enhance vascular development and protection. This investigation examined whether ECFCs from human umbilical cord blood (UCB) enhanced NVU development in FGR and appropriate for gestational age (AGA) fetal sheep. Methods: Twin-bearing ewes had surgery performed at 88-90 days' gestation, inducing FGR in one fetus. At 113 days, ECFCs (1 × 10 Results: Twenty-four fetal lambs, arranged in four groups: AGA (n = 7), FGR (n = 5), AGA + ECFC (n = 6), and FGR + ECFC (n = 6), were included in analyses. FGR resulted in lower body weight than AGA (P = 0.002) with higher brain/body weight ratio (P = 0.003). ECFC treatment was associated with increased vascular density throughout the brain in both AGA + ECFC and FGR + ECFC groups, as well as increased vascular-astrocyte coverage and VEGF expression in the cortex (P = 0.003, P = 0.0006, respectively) and in the subcortical white matter (P = 0.01, P = 0.0002, respectively) when compared with the untreated groups. Conclusions: ECFC administration enhanced development of NVU components in both the AGA and FGR fetal brain. Further investigation is required to assess how to optimise the enhanced angiogenic capabilities of ECFCs to provide a therapeutic strategy to protect the developing NVU against vulnerabilities associated with FGR.
MeSH term(s)	Animals ; Sheep ; Female ; Humans ; Animals, Newborn ; Brain ; Fetus ; Brain Injuries/metabolism ; Fetal Growth Retardation/metabolism ; Fetal Blood/metabolism ; Body Weight
Language	English
Publishing date	2023-02-14
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2548671-8
ISSN	1757-6512 ; 1757-6512
ISSN (online)	1757-6512
ISSN	1757-6512
DOI	10.1186/s13287-023-03249-z
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