## Protocol Section
### Identification Module
**NCT ID:** NCT01061879

**Brief Title:** Expansion of Umbilical Cord Blood Using a Unique Bio-system

**Official Title:** Ex Vivo Expansion of Umbilical Cord Blood Using a Unique Bio-system

#### Organization Study ID Info
**ID:** 11973
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-01-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-12-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Start Date
**Date:** 2010-02

**Status Verified Date:** 2012-12

#### Study First Post Date
**Date:** 2010-02-03
**Type:** ESTIMATED
**Study First Submit Date:** 2010-02-02
**Study First Submit QC Date:** 2010-02-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Kansas

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** By doing this study, researchers hope to develop a special technique and laboratory conditions to help support umbilical stem cell growth and multiplication.

In this project, researchers propose a three dimensional (3D) microenvironment that mimics the bone marrow stem cell microenvironment, with its supporting cells of osteoblasts and stromal cells. In theory, this will result in better expansion of cord blood stem cells ex vivo.

**Detailed Description:** To successfully expand umbilical cord blood stem cells ex vivo, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. First, bone osteoblasts are important in promoting hematopoietic stem cell expansion, accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure. The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in this created 3D bone structure. This is a unique design that has the potential to expand cord blood stem cells more efficiently.

### Conditions Module

**Conditions:**

- Pregnancy

**Keywords:**

- umbilical cord

- umbilical cord blood collection

- pregnancy

### Design Module

#### Bio Spec

**Description:** umbilical cord

**Retention:** SAMPLES_WITH_DNA

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** To successfully expand the umbilical cord blood stem cells, a microenvironment that resembles the stem cell microenvironment, or stem cell 'niche' should be created. In designing this bio-system, we make use of several observations. Firstly, bone osteoblasts are important in promoting hematopoietic stem cell expansion , accordingly, this bio-system will ensure the physical proximity of the cord blood stem cells to a 3D bone tissue derived from mesenchymal stem cells (MSCs). These MSCs will be isolated from Wharton's jelly, and by using an osteogenic medium and special scaffolds, these MSCs will differentiate into osteogenic progenitors creating a 3D bone structure . The other observation is that, co-culture of cord blood stem cells with mesenchymal stem cells is superior to liquid cultures in terms of ex vivo expansion , accordingly, in this experiment, undifferentiated MSCs will be co-cultured with cord blood stem cells in the created 3D bone structure.

**Measure:** bio-system for ex-vivo expansion of umbilical cord blood stem cells

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* females that consent to permit researchers collect the discarded umbilical cords from the placenta and use for research purposes.

Exclusion Criteria:

-

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** umbilical cord collection from full-term caesarian section/normal vaginal delivery patients

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kansas City

**Country:** United States

**Facility:** University of Kansas Medical Center

**State:** Kansas

**Zip:** 66160

#### Overall Officials

**Official 1:**

**Affiliation:** University of Kansas Medical Center

**Name:** Omar Aljitawi, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
