Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome
NCT ID: NCT01883076
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2013-05-15
2021-04-28
Brief Summary
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The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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autologous cell-based delivery
autologous cell-based delivery a target dose of 3 million cells / kg of body weight will be delivered into the right heart muscle at the time of surgery. Cells are derived from autologous (self) umbilical cord blood.
autologous cell-based delivery
autologous cells (derived from "self")
Interventions
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autologous cell-based delivery
autologous cells (derived from "self")
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. No aerobic or anaerobic bacterial growth after 14 days
2. Greater than 70% cell viability pre-freeze
3. Total Nucleated Cells (TNC) concentration of 30-42 x 106 cells/mL (pre-freeze)
4. Minimum of one (1) vial of cells
5. Mononuclear cell percentage of greater than 50%
6. Endotoxin result of less than 16 Endotoxin Units (EU)/mL.
2. Mother's serology test results are negative for HIV, Hepatitis B, and Hepatitis C.
3. Individuals with HLHS having undergone Stage I surgical palliation and undergoing planned Stage II palliative Glenn surgery.
4. Ages up to 18 months are eligible if written informed consent can be obtained from both parents (unless one parent is not reasonably available) and/or legal guardians.
Exclusion Criteria
2. History of dimethyl sulfoxide (DMSO) reaction for either the child or mother.
3. Parent(s)/child unwilling to participate.
4. Child with severe chronic diseases, extensive extra-cardiac syndromic features, or history of cancer.
5. Child not completing all pre-procedure work-up within 10 days of the Stage II Glenn surgery as listed in section 6 of this protocol AND lack of pre-procedure work-up documented as a safety concern by a site investigator.
6. Child who's cells have been compromised after meeting cell release criteria (as defined in Inclusion Criterion #1).
7. Child with the following complications of their congenital heart disease:
1. Any condition requiring urgent, or unplanned procedure within 15 days prior to Stage II surgical repair
2. Severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure)
3. Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome during or after Stage II surgical repair.
18 Months
ALL
No
Sponsors
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University of Oklahoma
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Hospitals and Clinics of Minnesota
OTHER
Children's Hospital Los Angeles
OTHER
Children's Hospital Colorado
OTHER
Mayo Clinic
OTHER
Timothy J Nelson, MD, PhD
OTHER
Responsible Party
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Timothy J Nelson, MD, PhD
Program Director
Principal Investigators
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Timothy J Nelson, M.D., Ph.D.
Role: STUDY_DIRECTOR
Mayo Clinic
Muhammad Y Qureshi, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Harold M Burkhart, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oklahoma University Children's Hospital
Joseph W Rossano, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
David M Overman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Minnesota
Ram Kumar Subramanyan, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
James Jaggers, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Oklahoma University Children's Hospital
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-008521
Identifier Type: -
Identifier Source: org_study_id
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