Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

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Brief Title

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

Official Title

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

Brief Summary

      The objective of the study is to enable access to sibling or autologous umbilical cord blood
      (UCB) infusions for children with various brain disorders.

      The use of UCB in this fashion is based on safety and efficacy data from prior and ongoing
      clinical trials at Duke University Medical Center in over 700 patients with these diagnoses
      infused with autologous or sibling UCB over the past decade.
    

Detailed Description

      The primary purpose of this protocol is to enable access to sibling or autologous umbilical
      cord blood for children with various brain disorders. Children with autism, apraxia, cerebral
      palsy, hydrocephalus, hypoxic brain injury, stroke, and other brain injuries will be eligible
      if they do not qualify for or are unable to participate in another active clinical trial at
      Duke. Children with qualifying partially or fully matched sibling or autologous cord blood
      units will be eligible. The family will be enrolled on the screening protocol, "A Research
      Database and Screening Protocol for Children with Brain Injuries Potentially Undergoing
      Cellular Therapy or Other Clinical Trials," Pro00063563. Information may be obtained under
      this protocol including but not limited to: diagnostic information, genetic testing, videos
      and pictures of the child, cord blood report, etc. The PI or her designee will review this
      information to determine if the child might be eligible for a cord blood infusion(s) on this
      expanded access protocol.

      If eligible, the child must come to Duke with a parent or legal guardian for clinical
      evaluations and infusion of the umbilical cord blood unit. Parents will be required to
      participate in remote follow-up phone calls and be willing to complete questionnaires for
      safety follow-up.
    


Study Type

Expanded Access




Condition

Autism Spectrum Disorder

Intervention

Cord Blood Infusion


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological





Eligibility Criteria

        Inclusion Criteria:

          1. Have a qualifying sibling or autologous cord blood unit

          2. Be < 26 years of age at the time of consent.

          3. Have given written informed consent according to FDA guidelines (or consent of
             parent/legal guardian as applicable).

          4. Have baseline blood counts and basic chemistries within normal for age.

          5. Have a normal absolute lymphocyte count (ALC) for age on baseline blood count and
             differential.

        Exclusion Criteria:

          1. Documented HIV or Hepatitis or other disease transmittable through the blood.

          2. A cord blood unit that fails to meet specifications

          3. Refusal of consent

          4. Uncontrolled seizure disorder

          5. Uncontrolled infection

          6. Diagnosed with a genetic or metabolic disorder related to the neurologic condition

          7. History of an immune deficiency

          8. History of treatment with chemo or immunosuppressive therapy

          9. History of previous allogeneic cell therapy. If previously enrolled on another Duke
             cell therapy protocol the subject can still be considered for enrollment on this study

         10. Need for mechanical ventilation or chronic O2 support

         11. History of inability to protect the airway

         12. Eligibility for an active clinical trial of cellular therapies at Duke
      

Gender

All

Ages

N/A - 26 Years


Contacts

Joanne Kurtzberg, 9196681102, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03327467

Organization ID

Pro00083888


Responsible Party

Sponsor-Investigator

Study Sponsor

Joanne Kurtzberg, MD


Study Sponsor

Joanne Kurtzberg, Principal Investigator, Duke University


Verification Date

August 2022