Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center, Houston
About this trial
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).
Eligibility criteria
Qualifiers
Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.
Age: 18-65 years
Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants.
Disqualifiers
MSCs transplant within the last six months
Inability to comply with study protocol
Patient at high suicidal risk according to clinicians' judgement
History of previous brain injury; neurologic impairment and/or deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT > 2 x ULN (non-contusion related), and/or T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC<3,000 cells/ml at admission; HIV, splenectomy or cancer
Trial design
Treatments tested in this trial
- Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov