Phase 2
Completed N=16
Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects
Source: ClinicalTrials.gov NCT02886884 ↗Enrolled (actual)
16
Serious AEs
18.8%
Results posted
May 2022
Primary outcomePrimary: Number of Treatment Emergent Serious Adverse Events (TE-SAEs) — 0; 0; 0; 0 Treatment Emergent SAE
Summary
This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Serious Adverse Events (TE-SAEs) |
0; 0; 0; 0 | — |
| SECONDARY EPC-CFU Levels |
2.06; 3.16; 2.37; 1.93; 3.39; 5.50 | — |
| SECONDARY CRP Marker Levels |
— | — |
| SECONDARY Circulating Angiogenic Factor Levels |
— | — |
| SECONDARY Flow Mediated Diameter Percentage (FMD%) |
2.55; 4.33; 4.55; 3.11; 2.86; 4.76 | — |
| SECONDARY Circulating Inflammatory Marker Levels |
— | — |
| SECONDARY Tumor Necrosis Factor (TNF) Alpha Levels |
0.79; 0.80; 0.85; 0.80; 0.74; 0.86 | — |
Eligibility Criteria
Inclusion Criteria
- Be ≥ 21 and 45% by gated blood pool scan, two- dimensional echocardiogram, cardiac MRI, cardiac CT or left ventriculogram within the prior 3 months.
- Have Diabetes mellitus type 2 documented by hemoglobin adult type 1 component (A1C) > 7% or on medical therapy for diabetes.
- Females of childbearing potential must use two forms of birth control for the duration of the study. Female subjects must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
Exclusion Criteria
In order to participate in this study, a subject Must Not:
- Be younger than 21 years or older than 90 years of age.
- Have a baseline glomerular filtration rate 8.5%.
- Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
- Have a hematologic abnormality as evidenced by hematocrit 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.
- Have Lymphadenectomy or Lymph node dissection in the right arm.
- Be an organ transplant recipient or have a history of organ or cell transplant rejection.
- Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively- treated basal cell or squamous cell carcinoma, or cervical carcinoma.
- Have a condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or Tumor Necrosis Factor - alpha (TNFα) antagonists.
- Be serum positive for HIV, Syphilis - VDRL (Confirmation with FTA-ABS if needed (Syphilis)), 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.
- Be pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods.
- Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.
Data sourced from ClinicalTrials.gov (NCT02886884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.