Bone Marrow Procurement for a Mesenchymal Stem Cell Bank (H-35907)

The purpose of this study is to obtain bone marrow to separate mesenchymal stem cells for creation of a stem cell bank. The bone marrow aspirates will be done in the Center for Cell and Gene Therapy Unit at Houston Methodist Hospital by staff trained in these procedures. We have significant experience with such procedures.

We will collect 20 mL (4 teaspoons) of bone marrow from each subject following standard procedures. After collection, the bone marrow will be evaluated in a laboratory. A portion of the marrow will be frozen directly. The frozen portion of the marrow will be stored as a back-up in the event that over time our processes for identifying, extracting, and expanding MSCs improve. The remainder of the bone marrow will be treated to identify mesenchymal stem cells (MSC) and grow them from the bone marrow.

These MSCs will then be allowed to multiply in the laboratory. Once we have up to 10e9 MSC, we will then freeze the cells for storage. Any positive test results from infectious disease testing will be reported to local health authorities but no information that could identify the subject would be included. All evaluation, manipulations and storage of the stem cells will be done in the CAGT GMP facility at Texas Children's Hospital.