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Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression (ANU)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified March 2017 by Joshua M Hare, University of Miami
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier:
NCT02675556
First received: February 1, 2016
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
This study is intended to evaluate the safety and potential efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion versus placebo in patients with Treatment Resistant Depression.

Condition Intervention Phase
Treatment Resistant Depression Drug: Allo-hMSCs Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Phase I, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients With Treatment Resistant Depression.

Further study details as provided by Joshua M Hare, University of Miami:

Primary Outcome Measures:
  • Incidence of any treatment-emergent serious adverse events (TE-SAEs) [ Time Frame: One month post infusion ]
    defined as a composite of acute suicidality, and hospitalization for suicide attempts.


Secondary Outcome Measures:
  • Reduction of Inflammation [ Time Frame: Week 12 ]
    Reduction of Inflammation: Change in serum concentrations of C-Reactive Protein (CRP)


Other Outcome Measures:
  • Reductions in serum concentrations [ Time Frame: Week 12 ]
    Reductions in serum concentrations of other inflammatory markers;

  • Reduction in Depressive Symptoms [ Time Frame: Week 12 ]
    Reduction in Depressive Symptoms due to change in Montgomery-Asberg Depression Rating Scale (MADRS)

  • Reduction in Anhedonia [ Time Frame: Week 12 ]
    Reduction in Anhedonia due to change in the Snaith Hamilton Pleasure Scale

  • Improvements in Cognition [ Time Frame: Week 12 ]
    Improvements in Cognition as a result of changes in Brief Assessment of Cognition for Affective Disorders (BAC-A), Performance Based Skills Assessment (UPSA-B), and Specific Level of Functioning (SLOF) scores

  • Improvements in Functional Capacity [ Time Frame: Week 12 ]
    Improvements in Functional Capacity as a result of changes in Brief Assessment of Cognition for Affective Disorders (BAC-A), Performance Based Skills Assessment (UPSA-B), and Specific Level of Functioning (SLOF) scores

  • Improvements in everyday functioning [ Time Frame: Week 12 ]
    Improvements in everyday functioning as a result of changes in Brief Assessment of Cognition for Affective Disorders (BAC-A), Performance Based Skills Assessment (UPSA-B), and Specific Level of Functioning (SLOF) scores

  • Mediating effects of child abuse and neglect. [ Time Frame: week 12 ]
    Mediating effects of child abuse and neglect.


Estimated Enrollment: 80
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2025
Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic hMSCs
Forty (40) subjects will be treated with a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10^6 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.
Drug: Allo-hMSCs
a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10^6 (100 million) allo-hMSCs of cells
Other Names:
  • Allogeneic Human Mesenchymal Stem Cells
  • Stem Cells
Placebo Comparator: Placebo
Forty (40) subjects will be treated with a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.
Drug: Placebo
a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A

Detailed Description:

This is a phase I study, with eighty (80) patients fulfilling all inclusion/exclusion criteria's will be randomly assigned to receive allogeneic Human Mesenchymal Stem Cell (hMSCs) or placebo in a 1:1 blinded fashion.

40 patients will receive a single administration of allogeneic hMSCs and another 40 patients will receive a single administration of Placebo in a 1:1 blinded fashion.

Following infusion, patients will be followed at 2, 4, 6, 8, 10 and 12 week's post-infusion to complete all safety and efficacy assessments. Patients will additionally be followed for up to 12 months post-infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent.
  • Subjects age equal or greater than 18 and equal or less than 75 years at the time of signing the Informed Consent Form.
  • Diagnosis of Treatment resistant depression (Failed at least two adequate trials of antidepressant monotherapy or antidepressant augmentation with an antipsychotic or lithium during the current episode)
  • Patients who are receiving a third or more treatment will only be entered if they have not responded to the current treatment.
  • Experiencing a current Major Depressive Episode (fulfilling Structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria per Structured Clinical Interview for DSM (SCID) for categorical diagnosis, and the Hamilton Depression Rating Scale for Depression (HAM-D))
  • Hamilton Depression Rating Scale 21-item score greater than 18
  • Adequacy of previous failed antidepressant trials will be defined using standard criteria by Massachusetts General Hospital (MGH) of patients with a score greater than 2.5
  • Increased inflammation ([Serum CRP] greater than 3.0 mg/L)

Exclusion Criteria:

In order to participate in this study, a patient Must Not:

  • Be a female who is pregnant, nursing, or of childbearing potential, while not practicing effective contraceptive methods. (Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.)
  • Female subjects must have an Follicle stimulating hormone (FSH) less than 25.8 IU/L
  • Inability to perform any of the assessments required.
  • Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets<80,000/mm3, International Normalized Ratio (INR) > 1.5 not due to a reversible cause (i.e.

Coumadin), aspartate transaminase, alanine transaminase, or alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 1.8 mg/dl (unless due to a benign cause).

  • Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia)
  • Serious comorbid illness or any other condition (Such as bipolar, schizophrenia or schizoaffective disorder) that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
  • Have acute suicidality
  • Prior history of a suicide attempt
  • Active psychotic disorder, eating disorder, or substance use disorder within 6 months of enrollment
  • Treatment with any psychotropic (including hypnotic), steroidal, or anti- inflammatory medication (including Non steroid Anti-Inflammatory Drug) within 2 weeks of treatment randomization or 6 weeks for fluoxetine.
  • First major depressive episode after 50 years of age.
  • Have known allergies to penicillin or streptomycin.
  • Hypersensitivity to dimethyl sulfoxide (DMSO).
  • Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively- treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma.
  • Have a non-pulmonary condition that limits lifespan to less than 1 year.
  • Have a history of drug or alcohol abuse within the past 24 months.
  • Be serum positive for HIV, Hepatitis B surface antigen or Viremic hepatitis C.
  • Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02675556

Contacts
Contact: Joshua M Hare, MD 305-243-5579 jhare@med.miami.edu
Contact: Study Coordinators 305-243-7444 ISCIStudyinfo@miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Not yet recruiting
Miami, Florida, United States, 33136
Contact: Joshua M Hare, MD    305-243-5579    J.Hare@med.miami.edu   
Contact: Marietsy Pujol, MBA    305-243-7444      
Sub-Investigator: Joshua M Hare, MD         
Principal Investigator: Charles Nemeroff, MD         
Sponsors and Collaborators
Joshua M Hare
Investigators
Study Director: Joshua M Hare, MD ISCI / University of Miami Miller School of Medicine
  More Information

Responsible Party: Joshua M Hare, Sponsor - Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT02675556     History of Changes
Other Study ID Numbers: 20140917
Study First Received: February 1, 2016
Last Updated: March 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua M Hare, University of Miami:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2017