Assay for the Prediction of Therapeutic Effectiveness or Potency of Mesenchymal Stem Cells, and Methods of Using Same
AssigneeAllocure, Inc.
InventorsRobert M. Brenner, Ali S. Mohamed, Dena Minning
Life of this patent
Estimating the term…
Abstract
The invention relates to assays for testing the therapeutic effectiveness of mesenchymal stem cell (MSC) populations by determining the number of GT repeats in the heme oxygenase-1 (HO-1) promoter region of both alleles.
Claims103
A method of generating a population of human mesenchymal stromal cells (MSCs), the method comprising:
- (a) obtaining human MSCs;
- and
- (b) determining the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles.
A method of assaying the therapeutic effectiveness of human mesenchymal stromal cells (MSCs) for treating a pathology in a subject comprising:
- (a) obtaining a population of human MSCs;
- and
- (b) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles to determine whether the MSCs have short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the population contains MSCs that are therapeutically effective.
A method of selecting donors having therapeutically effective human mesenchymal stromal cells (MSCs) for treating a pathology in a subject comprising:
- (a) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles of a potential human bone marrow donor to determine whether the potential donors has short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the potential donor would provide MSCs that are superior for therapeutic uses, and
- (b) selecting those donors having such MSCs.
A method of treating an MSC-related pathology in a subject in need thereof comprising:
- (a) obtaining a population of human MSCs;
- (b) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles to determine whether the MSCs have short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the population contains MSCs that are therapeutically effective;
- and
- (c) administering any effective dose of the therapeutically effective MSCs to the subject, thereby treating the MSC-related pathology in the subject.
A method of treating an MSC-related pathology in a subject in need thereof comprising:
- (a) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles of a potential human donor to determine whether the potential donor has short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the potential donor would provide MSCs that are superior for therapeutic uses;
- (b) selecting those donors having such MSCs;
- and
- (c) administering any effective dose of the therapeutically effective MSCs to the subject, thereby treating the MSC-related pathology in the subject.
A kit comprising reagents for the analyzing the number of GT repeats present in the HO-1 promoter region of both alleles in a population of human MSCs.
A method of producing a dosage form of therapeutically effective human MSCs comprising:
- (a) obtaining a population of human MSCs;
- (b) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles to determine whether the MSCs have short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the population contains MSCs that are therapeutically effective, and
- (c) selecting therapeutically effective human MSCs.
- thereby producing a dosage form of human MSCs.
A method of producing a dosage form of therapeutically effective MSCs comprising:
- (a) analyzing the number of GT repeats present in the heme oxygenase-1 (HO-1) promoter region of both alleles of a potential human donor to determine whether the potential donor has short, medium, or long alleles, wherein the presence of two short alleles, two medium alleles, or one short allele and one medium allele indicates that the potential donor would provide MSCs that are superior for therapeutic uses, and
- (b) selecting those donors having such MSCs
- thereby producing a dosage form of human MSCs.
A population of human MSCs, wherein the human MSCs in the population contain ≦32 GT repeats in each allele of the HO-1 promoter region.
A population of human MSCs comprising at least 75% human MSCs, wherein:
- a) the human MSCs in the population contain ≦32 GT repeats in each allele of the HO-1 promoter region;
- b) the human MSCs in the population have been in platelet lysate supplemented culture media and express Prickle 1 at a higher degree than MSCs that have been cultured in fetal calf serum supplemented culture media;
- c) the human MSCs are cultured to between 80 and 95% confluence;
- d) the population does not contain detectable levels of infectious agents;
- and
- e) the human MSCs in the population have only undergone fewer than 30 population doublings.
Dependencies are inferred from the claim text.