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

NCT02675556 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 20140917
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Incidence of any treatment-emergent serious adverse events (TE-SAEs)

  defined as a composite of acute suicidality, and hospitalization for suicide attempts.

  One month post infusion

Secondary Outcomes (1)

• Reduction of Inflammation

  Week 12

Other Outcomes (7)

• Reductions in serum concentrations

  Week 12

• Reduction in Depressive Symptoms

  Week 12

• Reduction in Anhedonia

  Week 12

Study Arms (3)

Allogeneic hMSCs

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Pilot - Allogeneic hMSCs

EXPERIMENTAL

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

Interventions

Allo-hMSCs DRUG

a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10\^6 (100 million) allo-hMSCs of cells

Also known as: Allogeneic Human Mesenchymal Stem Cells, Stem Cells

Allogeneic hMSCs; Pilot - Allogeneic hMSCs

Placebo DRUG

a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or equal to 2.5
• Increased inflammation (\[Serum CRP\] greater than 3.0 mg/L)

You may not qualify if:

• In order to participate in this study, a patient Must Not:
• 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.)
• Inability to perform any of the assessments required.
• 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).
• 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 subject or preclude successful completion of the study.
• Have acute suicidality
• Prior history of a suicide attempt, within the past year.
• Active psychotic disorder, eating disorder, or substance use disorder within 6 months of enrollment
• Treatment with any medication that, in the opinion of the Investigator, may compromise the safety of the subject or affect the validity of the data or the study endpoints.
• First major depressive episode after 50 years of age.
• Have known allergies to penicillin or streptomycin.
• Have hypersensitivity to dimethyl sulfoxide (DMSO).
• 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.
• Have a non-pulmonary condition that limits lifespan to \< 1 year.

Sponsors & Collaborators

• Joshua M Hare: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Joshua M Hare, MD

  ISCI / University of Miami Miller School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor - Investigator

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 5, 2016
• Study Start: October 31, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

US (1)