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



Status:Terminated
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:4/3/2019
Start Date:October 31, 2017
End Date:March 26, 2019

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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.

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.

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.

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 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.

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.
We found this trial at
1
site
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Phone: 305-243-5579
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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