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Trial record 40 of 201 for:    Depressive Disorder | "Depressive Disorder, Treatment-Resistant"

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

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ClinicalTrials.gov Identifier: NCT02675556
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Brief Summary:
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 or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Allo-hMSCs Drug: Placebo Phase 1

Detailed Description:

This is a phase I study, with eight subjects in the pilot phase and eighty (80) subjects 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.

The 8 subjects in the pilot phase will receive a single infusion of 100 million hMSCs.

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. During these 12 weeks starting after the week 2 visit subjects will have a phone call in-between their visits. Patients will additionally be followed for up to 12 months post-infusion.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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.
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Pilot - Allogeneic hMSCs
Eight (8) 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




Primary Outcome Measures :
  1. 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 :
  1. Reduction of Inflammation [ Time Frame: Week 12 ]
    Reduction of Inflammation: Change in serum concentrations of high sensitivity C-Reactive Protein (hs-CRP)


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

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

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

  4. 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

  5. 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

  6. 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

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



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Provide written informed consent.
  2. Subjects age equal or greater than 18 and equal or less than 75 years at the time of signing the Informed Consent Form.
  3. 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)
  4. Patients who are receiving a third or more treatment will only be entered if they have not responded to the current treatment.
  5. 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))
  6. Hamilton Depression Rating Scale 21-item score greater than 18
  7. Adequacy of previous failed antidepressant trials will be defined using standard criteria by Massachusetts General Hospital (MGH) of patients with a score greater than or equal to 2.5
  8. Increased inflammation ([Serum CRP] greater than 3.0 mg/L)

Exclusion Criteria:

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

  1. Women who are pregnant, nursing, or of childbearing potential, while not practicing effective contraceptive methods. (Female subjects of childbearing potential must undergo a serum or urine pregnancy test at screening and within 36 hours prior to infusion.)
  2. Inability to perform any of the assessments required.
  3. Have clinically significant abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets<80,000/mm3, 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).
  4. Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia)
  5. 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 subject or preclude successful completion of the study.
  6. Have acute suicidality
  7. Prior history of a suicide attempt, within the past year.
  8. Active psychotic disorder, eating disorder, or substance use disorder within 6 months of enrollment
  9. Treatment with any psychotropic (including hypnotic), steroidal, or anti-inflammatory medication (including NSAIDSs) within 2 weeks of treatment randomization or 6 weeks for fluoxetine.
  10. First major depressive episode after 50 years of age.
  11. Have known allergies to penicillin or streptomycin.
  12. Have hypersensitivity to dimethyl sulfoxide (DMSO).
  13. Have a clinical history of malignancy within 5 years (i.e., subjects 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.
  14. Have a non-pulmonary condition that limits lifespan to < 1 year.
  15. Have a history of drug or alcohol abuse within the past 24 months.
  16. Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675556


Contacts
Contact: Joshua M Hare, MD 305-243-5579 jhare@med.miami.edu
Contact: Andrew Kimmel 305-243-5510 a.kimmel@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine 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

Responsible Party: Joshua M Hare, Sponsor - Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT02675556     History of Changes
Other Study ID Numbers: 20140917
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
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