The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.

开始日期2013-06-01

申办/合作机构

University of Texas Health Science Center at Houston

[+3]

NCT01273337 / Unknown status临床2期

A Phase 2 Randomized, Controlled Study With a Phase 1 Safety Cohort Testing ALD-401 Derived From Autologous Bone Marrow Delivered Via Intracarotid Infusion in Subjects With Ischemic Stroke With Blinded Assessments

The purpose of this study is to demonstrate the safety of the delivery of ALD-401 by intracarotid infusion and to assess efficacy of treatment in subjects who have had unilateral, predominately cortical, ischemic strokes in the middle cerebral artery (MCA). ALD-401 is made from the stroke patient's bone marrow and infused 13-19 days after the stroke.

开始日期2011-03-01

申办/合作机构

Aldagen, Inc.

NCT01003912 / Withdrawn临床1期IIT

Treatment of Early Infantile-Onset Lysosomal Storage Diseases With Fetal Umbilical Cord Blood (UCB) Transplantation

The purpose of this study is to determine if it is safe to administer unrelated umbilical cord blood to pregnant women in their first trimester of pregnancy with a fetus that has a known diagnosis of certain lysosomal storage diseases. These diseases are known to cause severe and irreversible neurological disability in early infancy and which are lethal in childhood.

开始日期2009-10-01

申办/合作机构

Duke University

[+1]

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0 项与 Aldagen, Inc. 相关的专利（医药）

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项与 Aldagen, Inc. 相关的文献（医药）

2012-01-01·Journal of Stem Cell Research & Therapy

Mechanisms of Action of Human Aldehyde Dehydrogenase Bright Cells in Therapy of Cardiovascular Diseases: Expression Analysis of Angiogenic Factors and Aldehyde Dehydrogenase Isozymes

作者: Balber, Andrew E. ; Storrie White, Hannah ; Gentry, Tracy ; Smith, Liisa

Human stem cell populations that express high aldehyde dehydrogenase activity [ALDHbr cells] have angiogenic activity in preclin. models and have been used safely to treat patients in early clin. trials.Bone marrow ALDHbr cells are being developed for therapeutic use in ischemic cardiovascular diseases.The mechanisms by which ALDHbr cells repair ischemic tissue are unknown, but available data suggest that angiogenic factors released by ALDHbr cells are involved.Gene expression studies were performed, and bone marrow ALDHbr cells were found to express 69 of 84 angiogenic factors tested.The 25 most highly expressed genes included soluble cytokines and growth factors, cytokine receptors, extracellular matrix proteins, and cell-cell signaling receptors.ALDHdim bone marrow cells that do not express high levels of ALDH and that have no angiogenic activity in preclin. models expressed a different group of genes.CD105 and Ephrin B4 transcripts were expressed about 65-fold more highly in ALDHbr than ALDHdim cells, and expression of these proteins was demonstrated in ALDHbr cells by flow cytometry.Expression anal. probing all 19 ALDH isoenzymes and immunofluorescence both demonstrated that ALDH1A1, an enzyme that can generate retinoic acids from retinaldehyde, was the ALDH isoenzyme most highly over expressed in ALDHbr cells compared to ALDHdim cells.Transwell studies demonstrated that ALDHbr cells responded to hypoxic conditions and to factors released from human endothelial vein cells (HUVEC) with changes in expression of specific angiogenic factors.Soluble factors released from ALDHbr cells in transwell cultures under hypoxic conditions stabilized endothelial tubules formed by HUVEC.The results are consistent with the hypothesis that human bone marrow ALDHbr cells can promote angiogenesis in ischemic tissues of patients with cardiovascular disease by several mechanisms including the release of soluble mediators.

2009-11-20·Blood

Creation of a Segment-Based Aldehyde Dehydrogenase Assay as a Biomarker for Cord Blood Potency.

作者: Balber, Andrew ; Page, Kristin M ; Gentry, Tracy ; Shoulars, Kevin ; Kurtzberg, Joanne

AbstractAbstract 3217Poster Board III-154Banked, unrelated umbilical cord blood units (CBU) provide an option for transplantation in patients where matched adult donors are unavailable. Current methods for selecting a suitable CBU for transplantation includes examining the human leukocyte antigen (HLA) matching, total nucleated cell (TNC) count, and viable CD34 counts on the unit prior to cryopreservation. However, up to 20% of patients experience primary graft failure following UCB transplantation (UCBT), suggesting that a rapid assay to assess CBU potency on the thawed unit prior to the release from the cord blood bank is needed. Preliminary clinical studies demonstrated that neutrophil and platelet engraftment as well as overall survival can be predicted with post-thaw colony forming units (CFU). The usefulness of post-thaw CFU as a potency assay is limited both by time (14 days) and variability. However, CFUs in fresh cord blood are highly correlated with the number of cells expressing the enzyme aldehyde dehydrogenase (ALDHbr cells), which is enriched in hematopoietic stem cells. Therefore, an ALDHbr assay for segments attached to CBUs was developed to measure potency for UCBT. Retrospective studies of transplanted CBUs indicated that engraftment success could be accurately predicted by the number of ALDHbr cells infused per kilogram. In order to facilitate prospective studies, the segment assay was modified to allow HLA matching, CFUs and the ALDHbr assay to be done from one CBU segment. Blood was withdrawn from the segment with a needle and 3 drops of blood (∼30 ml) were spotted onto a FTA card for the HLA confirmatory typing. The remainder of the blood was washed with 5% dextran/albumin (DA) to remove the DMSO. Following the removal of 100,000 white blood cells for CFUs, the segments were assessed using flow cytometry for ALDHbr [Aldecount®], CD45 (Phycoerythrin (PE)-labeled), 7-amino-actinomycin D (7-AAD, viability), Glycophorin A (PE-Cy5-labeled) and CD34 (Allophycocyanin (APC)-labeled). Total nucleated cell (TNC) count was obtained [Sysmex] and the total number of each cell population in the segment was calculated. This method reproducibly assays ALDHbr cells (∼85% CD34/45 positive) from a single segment in less than a day while allowing testing of routine parameters of the CBU (HLA matching, TNC, viable CD34) currently used to select units for transplantation. Furthermore, the assay produces reliable results when performed by people from different laboratories (Duke vs. MD Anderson) and on different cytometers (Accuri C6 vs. BD Bioscience Facscalibur). Therefore, this method will be suitable for further prospective studies on the predictive value of the ALDHbr assay to measure cord blood potency as an indicator of its ability to confer neutrophil and platelet engraftment and overall survival after UCBT.DisclosuresGentry: Aldagen, Inc: Employment. Balber:Aldagen, Inc: Employment, Equity Ownership. Kurtzberg:Aldagen, Inc: Research Funding.

2009-11-20·Blood

Human ALDH-Bright Bone Marrow Cells Produce Paracrine Factors That Protect Endothelial Cells From Hypoxic and Nutritional Stress.

作者: Smith, Liisa ; Balber, Andrew ; Gentry, Tracy ; White, Hannah

AbstractAbstract 3056Poster Board II-1032Human bone marrow cell populations isolated by sorting cells on the basis of high aldehyde dehydrogenase expression (ALDHbr cells) include endothelial, mesenchymal, and other progenitor cells (Gentry et al, 2007, Cytotherapy 9, 259). These cell populations home to and are retained at ischemic endothelium, induce angiogenesis, and effect restoration of tissue perfusion in a mouse hind limb ischemia model (Cappoccia et al, 2009 Blood 113, 5340.) Critical limb ischemia patients treated with ALDHbr cells in a Phase I/II clinical trial showed increased limb perfusion. We are studying paracrine and contact dependent mechanisms by which ALDHbr cells may repair damaged endothelium by measuring the protective effects of ALDHbr cells on early passage human umbilical vein endothelial cells (HUVEC) exposed to hypoxic and nutritional stress. ALDHbr cells migrated through membrane filters in response to supernatants conditioned by hypoxic HUVECs more rapidly than to normoxic HUVEC supernatants. ALDHbr cells attached to HUVECs that had been induced to form tubular structures on Matrigel®, and more ALDHbr cells decorated HUVEC tubules under hypoxic than normoxic conditions. ALDHbr cells and HUVECs expressed several adhesion molecule-ligand pairs, including VLA-1/VCAM, that are regulated by hypoxia and could mediate these interactions. While HUVEC tubules fell apart under hypoxic conditions, adding ALDHbr cells in a transwell culture system for 24 hours preserved the branching structure of hypoxic HUVEC tubule networks. Gene array studies demonstrated that ALDHbr cells highly express several angiogenic growth factors, cytokines and matrix remodeling molecules. Expression of proteins corresponding to many of these gene products, including members of the ephrin-Eph receptor family that can direct endothelial growth, has been confirmed by flow cytometry. Additionally, 29 angiogenic factors including angiopoietin 2, VEGF-A,C, and D, and MMP2 were upregulated under hypoxic conditions. Gene array and flow cytometry showed that hypoxic HUVECs expressed surface receptors for many of the angiogenic factors expressed by ALDHbr cells. In hypoxic transwell cultures, ALDHbr cells specifically induced HUVECs to express six angiogenic factors that were not induced by hypoxia alone. ALDHbr cells protected HUVECs from apoptosis and necrosis induced by serum starvation when added to cultures at the time of or 24 hours following medium shift. Thus, in addition to providing progenitor cells that can potentially participate in angiogenesis, ALDHbr cell populations can mediate repair of ischemic injury by releasing a variety of angiogenic and protective factors at sites of endothelial damage.DisclosuresSmith: Aldagen, Inc.: Employment. White:Aldagen, Inc.: Employment. Gentry:Aldagen, Inc.: Employment. Balber:Aldagen, Inc: Employment, Equity Ownership.

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