Trial Outcomes & Findings for A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes (NCT NCT02624804)

Last Updated: 2026-04-03

Results Overview

The primary study endpoint will be the occurrence of treatment-related adverse effects. Adverse events that occur during therapy (especially those that necessitate temporary or permanent discontinuation of therapy) and over the 12-month follow-up period will be assessed.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

12 months

Results posted on

2026-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Stem Cell Educator Therapy Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Stem Cell Educator Therapy Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Overall Study Screen Failure	5

Baseline Characteristics

A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stem Cell Educator Therapy n=13 Participants Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Sex: Female, Male Female	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Patients Experiencing Treatment Related Adverse Events

Outcome measures

Outcome measures
Measure	Stem Cell Educator Therapy n=8 Participants Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Number of Participants With Treatment Related Adverse Events	1 Participants

SECONDARY outcome

Timeframe: One week

Number of patients who were unable to complete SCE Therapy.

Outcome measures

Outcome measures
Measure	Stem Cell Educator Therapy n=8 Participants Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Number of Patients Unable to Complete Therapy	0 Participants

Adverse Events

Stem Cell Educator Therapy

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stem Cell Educator Therapy n=8 participants at risk Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Psychiatric disorders Depression	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.

Other adverse events

Other adverse events
Measure	Stem Cell Educator Therapy n=8 participants at risk Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes Stem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes
Gastrointestinal disorders Abdominal Pain	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
General disorders Body Aches	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
General disorders Chest Pain	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Nervous system disorders Dizziness	25.0% 2/8 • Number of events 2 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Nervous system disorders Headache	25.0% 2/8 • Number of events 2 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Metabolism and nutrition disorders Hypoglycemia	25.0% 2/8 • Number of events 2 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Infections and infestations Infection Strep Throat	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Nervous system disorders Paresthesia	37.5% 3/8 • Number of events 3 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.
Nervous system disorders Presyncope	12.5% 1/8 • Number of events 1 • From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.

Additional Information

Joshua Zenreich

Hackensack Meridian Health

Phone: 15519964248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place