Process for the preparation of a composition of genetically modified hematopoietic progenitor cells
AssigneeJohnson & Johnson Research Pty. Limited
InventorsGeoffrey P. Symonds, Rafael Amado, Lun-Quan Sun, Janet Macpherson, Greg Fanning, Wayne Gerlach
Life of this patent
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Abstract
Described are compositions and methods relating to gene therapy, particularly as applied to hematopoietic progenitor (HP) cells, to transduced cells and methods of obtaining them, and to methods of using them to provide prolonged engraftment of modified hematopoietic cells in human subjects. The invention particularly relates to ex vivo gene therapy of HP cells for treatment or prevention of HIV infection.
Claims20
A composition comprising a pharmaceutically acceptable carrier and at least 1.63×106 CD34+ hematopoietic cells per kg of body weight of a human subject to whom the composition is to be administered, at least 0.52×106 of such CD34+ hematopoietic cells being transduced with a viral construct which expresses an anti-HIV agent.
A composition comprising a pharmaceutically acceptable carrier and at least 1.63×106 CD34+ hematopoietic cells per kg of body weight of the subject to whom the composition is to be administered, at least 0.52×106 of such CD34+ hematopoietic cells being transduced with a viral construct which expresses an anti-HIV agent, wherein the composition is produced by a process comprising the steps of:
- (a) isolating CD34+ hematopoietic cells from the subject;
- (b) culturing the CD34+ hematopoietic cells with at least one cytokine;
- (c) transducing the CD34+ hematopoietic cells with the viral construct which expresses the anti-HIV agent in the presence of an agent which enhances colocalization of the cells and the viral construct;
- (d) washing the CD34+ hematopoietic cells, and
- (e) mixing the CD34+ hematopoietic cells with a pharmaceutically acceptable carrier, to thereby obtain the composition.
A composition comprising a pharmaceutically acceptable carrier and at least 1.63×106 CD34+ hematopoietic cells per kg of body weight of the human subject to whom the composition is to be administered, at least 0.52×106 CD34+ of such CD34+ hematopoietic cells being transformed with a gene of interest not found in the CD34+ cells prior to transformation.
20-42. (canceled)
Dependencies are inferred from the claim text.