Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury

A technology of oligodendrocytes and pluripotent stem cells, which can be applied to vertebrate cells, embryonic cells, animal cells, etc., and can solve problems such as development obstacles

Pending Publication Date: 2019-05-03
ASTERIAS BIOTHERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, obstacles remain in the development of such therapies for human clinical application
To date, there are no commercially available therapies utilizing human p

Method used

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  • Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury
  • Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury
  • Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury

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Experimental program
Comparison scheme
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Embodiment approach

[0088] Other implementations of the present disclosure include the following:

[0089] CLAIMS 1. A method of improving upper extremity motor function in a human subject suffering from a traumatic spinal cord injury, the method comprising administering to the subject a therapeutically effective amount of a composition comprising an allogeneic population of human oligodendrocyte progenitor cells.

[0090] 2. The method according to 1, wherein administering the composition comprises injecting the composition into the site of the spinal cord injury.

[0091] 3. The method according to 2, wherein the composition is injected about 2-10 mm caudal to the center of the spinal cord injury.

[0092] 4. The method according to 2, wherein the composition is injected about 5 mm caudal to the center of the spinal cord injury.

[0093] 5. The method according to any one of 1 to 4, wherein the human oligodendrocyte progenitor cells can be transplanted at the site of spinal cord injury.

[00...

Embodiment 1

[0118] Example 1: Phase 1 / 2a Escalating Dose Trial of AST-OPC1 in Patients with Fully Motorized C4-C7 Cervical Spinal Cord Injury

[0119] AST-OPC1 cells were generated by differentiating WA01(HI) hESCs from a master cell bank (MCB) as described in US Patent Application No. 15 / 136,316.

[0120] The initial clinical safety of AST-OPC1 was previously evaluated in a Phase 1 clinical trial enrolling patients with neurologically complete T3-T11 thoracic spinal cord injury (SCI). Based on favorable 5-year safety data from the Phase 1 trial, a Phase 1 / 2a trial was initiated to evaluate the safety and activity of AST-OPC1 at elevated doses in patients with sensorimotor complete C5-C7 cervical spinal cord injury.

[0121] In the phase 1 trial, 5 subjects received 2 × 10 6 A dose of AST-OPC1. The Phase 1 / 2a trial has enrolled and will continue to enroll subjects to receive 2×10 between 14 and 40 days after SCI 6 , 10×10 6 or 20×10 6 A continuous dose group of AST-OPC1. The study d...

Embodiment 2

[0124] Example 2: Comparison of Upper Extremity Motor Function Improvement in Groups 1 and 2 Patients Relative to Matched Historical Controls

[0125] The motor function improvement of subjects in Groups 1 and 2 following AST-OPC1 administration was compared to a closely matched historical group of traumatic SCI patients from the EMSCI (European Multicenter Study of Spinal Cord Injury) database of over 3300 patients. The matching criteria used to generate closely matched historical control data are shown in Figure 5 .

[0126] Comparative data for the 12-month follow-up period are presented at Figure 6A , Figure 6B and Figure 7 middle.

[0127] Figure 6A : Motor function recovery measured by change in UEMS over time in Group 2 subjects (10 x 106 AST-OPC1) was beneficial compared to closely matched historical controls, with a significant improvement at 3 months and a sustained increase over the 12-month period . Figure 6B : As expected, recovery of motor function (...

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Abstract

Methods and compositions for making and using pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury are disclosed.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application No. 62 / 394,226 filed September 14, 2016, U.S. Provisional Application No. 62 / 449,580 filed January 23, 2017, and U.S. Provisional Application No. 62 / 518,591, the disclosure of which is incorporated by reference in its entirety for all purposes. technical field [0003] The present disclosure relates to the field of oligodendrocyte progenitor and stem cell biology. More specifically, the present disclosure relates to oligodendrocyte progenitor cell compositions, and methods of use thereof. Background technique [0004] Each year, more than 12,000 Americans suffer from a spinal cord injury (SCI), and an estimated 1.3 million people in the United States suffer from a spinal cord injury. Traumatic SCI most commonly affects individuals in their 20s and 30s, resulting in high levels of permanent disability in younger and previously healthy individuals. Patients with sp...

Claims

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Application Information

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IPC IPC(8): A61K35/30A61P25/00C12N5/0735
CPCA61K35/30A61P25/00A61K45/06A61P37/06A61K9/0019C12N5/0606C12N5/0622
Inventor E·D·维尔斯三世J·S·莱布考斯基
Owner ASTERIAS BIOTHERAPEUTICS INC
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