University of Wisconsin hMSC Cell Bank: Bone Marrow Donor Protocol

University of Wisconsin (UW)

Status: Completed

Conditions: Graft Versus Host Disease (GVHD); Acute Myocardial Infarction (AMI)

Treatments: Procedure: Bone marrow aspirate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01463475

H-2010-0104

HHSN268201000010C (Other Grant/Funding Number)

Details and patient eligibility

About

The objective of this protocol is to use established standard criteria and methods for the collection of hMSC (human mesenchymal stromal cells) from healthy bone marrow donors. The hMSC collected from the donors will use to develop well-defined and reproducible cell banks. Standard manufacturing procedures and quality control testing methods will be used to characterize and evaluate the final cell product. After the cell banks are created, these cell products will be used in future translational or clinical research.

Full description

Cell banks will be manufactured and cellular products used for future translational or clinical research.

Enrollment: 3 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 to 35 years
• Willingness to provide written informed consent

Exclusion criteria

• Presence of risk factors for or clinical evidence of Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), Human transmissible spongiform encephalopathy (including Creutzfeldt-Jakob disease) treponema pallidum,
• Presence of communicable disease risk associated with xenotransplantation.
• Test positive for Human immunodeficiency virus (type 1 and 2), Hepatitis B, Hepatitis C, Human T-lymphotrophic virus (type I and II), cytomegalovirus (CVM), West Nile Virus, treponema pallidum.
• Use of investigational drug within 30 days or 5 half lives which ever is longer. Use of investigational implanted device.
• History of malignancy.
• Pregnancy
• In the opinion of the hematologist or the investigator, a condition that compromises the ability of the donor to safely provide BM donation.

Trial design

3 participants in 1 patient group

Bone Marrow Aspirate

Other group

Description:

A qualified enrolled donor will have an aspirate bone marrow draw.

Treatment:

Procedure: Bone marrow aspirate