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Mental Illness (Bipolar Depression) - Healing Genes
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Mental Illness (Bipolar Depression)

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Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression


Phase 1

DESCRIPTION:

Researchers at The University of Texas Health Science Center at Houston seek patients with  bipolar depression that failed to respond to two trials (during lifetime) with antidepressants and/or mood stabilizer with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, lurasidone, olanzapine) in adequate doses for at least 6 weeks. The trial investigates whether infusion of donor (allogeneic) Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs), cells that can grow into many different types of tissues, can reduce symptoms of bipolar depression.


PATIENT MUST:

  • Be 18 years to 65 years of age
  • Meet criteria specific to their disease
  • Not be pregnant and be willing to use contraception during the study
  • Not have high suicidal risk according to clinicians’ judgement

THE STUDY INVOLVES:

  1. Prescreening at the study site to confirm eligibility of the patient to participate
  2. Infusion of the allogeneic stem cells
  3. Lab and psychological assessments will continue for 26 weeks

LOCATIONS AND CONTACTS:

The study will be conducted at The University of Texas Health Science Center at Houston. Map.

 

Contacts:

Jair C Soares, MD, PhD  |  7134862627  |  [email protected]

Kathryn Durkin, BS  |  7134862627  |  [email protected]c.edu

 

SPONSOR INFORMATION:

The University of Texas Health Science Center, Houston

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03522545

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