OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome.

OssioStem 匹配的多能 MSC (M3):库存的低通道骨髓 MSC,用于治疗造血急性放射综合征。

基本信息

  • 批准号:
    10271661
  • 负责人:
  • 金额:
    $ 6.85万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2018
  • 资助国家:
    美国
  • 起止时间:
    2018-04-19 至 2023-03-31
  • 项目状态:
    已结题

项目摘要

Abstract of funded parent award The hematopoietic subsyndrome of acute radiation syndrome (H-ARS) is induced with even moderate exposure to ionizing radiation, which is lethal to hematopoietic stem cells (HSC) in the bone marrow (BM). Hematopoietic stem cell transplant (HSCT) is a potential life-saving treatment for H-ARS victims; however, it is not generally recommended due to commonly associated complication of graft-versus-host disease. Recent clinical trials, including that of our collaborator, have demonstrated that mesenchymal stromal/stem cell (MSC) infusions prevent/treat graft- versus-host-disease (GVHD) and reduce graft failure following HSCT. These salutary effects of MSC are due to potent immunomodulatory properties of the cells. Furthermore, MSC possess many other therapeutic properties shown to ameliorate pathologies associated with other ARS syndromes effecting the gastrointestinal system, skin and liver. Thus, MSC have the potential to treat the full spectrum of pathologies associated with ionizing radiation exposure. Ossium Health is developing a unique source of BM-derived multipotent MSC obtained from deceased organ donors. This cellular therapy, termed OssioStem-M3 (matched multipotent MSC) has a distinct advantage over other MSC sources in that it is donor-matched to a source for HSCT grafts (OssioStem-HSC) obtained from the same donors. Additionally, the large volumes of BM that can be obtained from a deceased donor yield exceptionally high numbers of MSC. This is important given that efficacy of MSC for supporting HSCT is negatively related to passage number; thus, low passage OssioStem-M3 is superior to “third party” MSC obtained from living donors which must be amplified through many passages. We propose here to optimize methods for isolation of OssioStem-M3 and thoroughly characterize their physical characteristics and biological function. We also propose to demonstrate efficacy in large (porcine) and small (mouse) models of H-ARS. Finally, we will build and test next generation devices for increasing the consistency and throughput of OssioStem- HSC production. The overall product of this research program will be a robust production process and a compelling preclinical package to justify definitive studies to support FDA approval for H-ARS under the Animal Rule. Abstract for supplement Supplemental funds are requested to cover a budget deficit caused by having to place the porcine H-ARS study at a new study site after the original site (Altasciences) discontinued their program. These funds will be used to cover the porcine H-ARS study budgetary shortfall and add a control arm. The supplemental amount requested is based on a quote provided by CRL on September 11, 2020 (quote number CRL272922). The amount quoted for 4 study groups was $389,580. With the inclusion of the additional of optional histopathology costs ($39,800), the total cost for the study was brought to $429,380 (ie., the sum of $389,580 + $39,800). Note that the histopathology costs were part of the original quote but were removed in consideration of meeting the originally budgeted amount for the study. Thus, the request for supplementing the CRL study is $115,380 which is the difference between $429,380 and $324,000.
资助父母奖励摘要

项目成果

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ERIK J. WOODS其他文献

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{{ truncateString('ERIK J. WOODS', 18)}}的其他基金

Novel strategies for storage and recovery of cadaveric bone marrow stem cells
尸体骨髓干细胞储存和恢复的新策略
  • 批准号:
    9910145
  • 财政年份:
    2018
  • 资助金额:
    $ 6.85万
  • 项目类别:
OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome.
OssioStem 匹配的多能 MSC (M3):库存的低通道骨髓 MSC,用于治疗造血急性放射综合征。
  • 批准号:
    9913377
  • 财政年份:
    2018
  • 资助金额:
    $ 6.85万
  • 项目类别:
OssioStem-matched multipotent MSC (M3): banked, low passage bone marrow MSC for treatment of hematopoietic acute radiation syndrome.
OssioStem 匹配的多能 MSC (M3):库存的低通道骨髓 MSC,用于治疗造血急性放射综合征。
  • 批准号:
    10392485
  • 财政年份:
    2018
  • 资助金额:
    $ 6.85万
  • 项目类别:
Novel strategies for storage and recovery of cadaveric bone marrow stem cells
尸体骨髓干细胞储存和恢复的新策略
  • 批准号:
    10116454
  • 财政年份:
    2018
  • 资助金额:
    $ 6.85万
  • 项目类别:
Novel Disaccharide-Based Cryopreservation Approach for Stable, -80°C Storage of Stem Cells
基于二糖的新型冷冻保存方法,用于-80℃稳定储存干细胞
  • 批准号:
    9410055
  • 财政年份:
    2017
  • 资助金额:
    $ 6.85万
  • 项目类别:
Optimizing Industrial-Scale GMP Processes for Recovering and Banking Deceased Donor Bone Marrow
优化工业规模 GMP 流程以回收和储存已故捐献者骨髓
  • 批准号:
    9926831
  • 财政年份:
    2017
  • 资助金额:
    $ 6.85万
  • 项目类别:
A Novel, Inexpensive Cryopreservation System for Stable -80 degree C Storage of A
一种新型、廉价的冷冻保存系统,可在 -80 摄氏度下稳定储存 A
  • 批准号:
    8199764
  • 财政年份:
    2011
  • 资助金额:
    $ 6.85万
  • 项目类别:
Therapeutic Angiogenesis by Universal Donor Endometrial Regenerative Cells
通用供体子宫内膜再生细胞的治疗性血管生成
  • 批准号:
    7804372
  • 财政年份:
    2010
  • 资助金额:
    $ 6.85万
  • 项目类别:
A Novel Device Design for Sperm Cryopreservation
精子冷冻保存的新型装置设计
  • 批准号:
    7665250
  • 财政年份:
    2009
  • 资助金额:
    $ 6.85万
  • 项目类别:
A NOVEL APPROACH TO GMP PRODUCTION, CRYOPRESERVATION AND DISTRIBUTION OF TOOTH DE
一种 GMP 生产、冷冻保存和分配牙齿的新方法
  • 批准号:
    7935375
  • 财政年份:
    2009
  • 资助金额:
    $ 6.85万
  • 项目类别:

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