Trial Outcomes & Findings for Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms (NCT NCT02846883)

Last Updated: 2024-08-09

Results Overview

This trial will test the hypothesis that MSCs, in a dose dependent fashion (1 x 10\^6 MSC/kg vs 3 x 10\^6 MSC/kg) promote the frequency and immune suppressor function of Treg cells as measured by mass cytometry compared to baseline.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

12 months

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Infusion of 1 Million Allogenic MSCs/kg In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)
Overall Study STARTED	6	10	12
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Intravenous Infusion of 1 Million Allogenic MSCs/kg In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)
Overall Study Death	0	1	1
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	1	0	0
Overall Study Study terminated by VA DSMB due to low enrollment	5	9	9
Overall Study Primary endpoint - endovascular aortic repair	0	0	1

Baseline Characteristics

Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Infusion of 1 Million Allogenic MSC's/Kg n=6 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg n=10 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) n=12 Participants In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Age, Continuous	64.17 years n=5 Participants	69 years n=7 Participants	67.75 years n=5 Participants	67.43 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	6 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
AAA size 3.0 - 3.9 cm (max. transverse diameter)	2 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
AAA size 4.0 - 5.0 cm (max. transverse diameter)	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Intravenous Infusion of 1 Million Allogenic MSCs/kg n=6 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg n=10 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) n=12 Participants In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)
Changes in Circulating Inflammatory Cell Phenotypes as Measured by Mass Cytometry	21.2 cells Standard Deviation 3.2	73.2 cells Standard Deviation 6.9	0.1 cells Standard Deviation 0.2

SECONDARY outcome

Timeframe: 12 months

The safety of systemic administration of allogeneic MSCs will be measured by treatment-related adverse events over a period of 12 months.

Outcome measures

Outcome measures
Measure	Intravenous Infusion of 1 Million Allogenic MSCs/kg n=6 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg n=10 Participants In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) n=12 Participants In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)
Incidence of Treatment Related Adverse Events at 12 Months Post MSC Administration as Evidenced by the Investigator	0 Participants	0 Participants	0 Participants

Adverse Events

Intravenous Infusion of 1 Million Allogenic MSCs/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Intravenous Infusion of 3 Million Allogeneic MSCs/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Intravenous Infusion of Plasmalyte A (Placebo)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Intravenous Infusion of 1 Million Allogenic MSCs/kg n=6 participants at risk In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered. The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of 3 Million Allogeneic MSCs/kg n=10 participants at risk In a randomized fashion, the MSCs, in the appropriate dose, will be shipped to the performance site where the MSCs will be thawed, diluted and administered.The thawed MSCs with be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry. Patients will be premedicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)	Intravenous Infusion of Plasmalyte A (Placebo) n=12 participants at risk In a randomized fashion, the Plasmalyte A will be shipped to the performance site where it will be thawed and administered. The Plasmalyte A will be administered within 4 hours to subjects in a monitored setting with telemetry and pulse oximetry as will be performed on active groups in order to protect the blinding of this study. Patients will be pre-medicated with hydrocortisone and diphenhydramine. All subjects will be monitored throughout the infusion procedure with vital signs and pulse oximetry at 15 minutes prior to infusion and ending 2 hours post procedure. They will also be evaluated for clinical signs of pulmonary distress. All patients will be admitted overnight for continued observation. The patient will be examined the following day and discharged home. MSCs: Intravenous infusion of 1 million allogeneic MSCs/kg. MSCs: Intravenous infusion of 3 million allogeneic MSCs/kg Placebo: Intravenous infusion of Plasmalyte A (placebo)
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	20.0% 2/10 • Number of events 2 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	25.0% 3/12 • Number of events 3 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Renal and urinary disorders Urinary Tract Infection	16.7% 1/6 • Number of events 3 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	0.00% 0/12 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Gastrointestinal disorders Pancreatitis, acute, recurrent	0.00% 0/6 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	8.3% 1/12 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
General disorders Pain, abdominal	50.0% 3/6 • Number of events 4 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	8.3% 1/12 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Musculoskeletal and connective tissue disorders Pain, back	16.7% 1/6 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	20.0% 2/10 • Number of events 2 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	16.7% 2/12 • Number of events 2 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Musculoskeletal and connective tissue disorders Pain, knee	16.7% 1/6 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	8.3% 1/12 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung nodule, new	0.00% 0/6 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	8.3% 1/12 • Number of events 2 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	8.3% 1/12 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Polyp Removal	0.00% 0/6 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	10.0% 1/10 • Number of events 1 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.	16.7% 2/12 • Number of events 2 • 12 months All adverse events (treatment related or otherwise) were collected throughout each participants enrollment at Day 0 (study product infusion), Day 7, Day 12, Month 1, Month 6 and Month 12 time points.

Additional Information

Michael P. Murphy, MD

Roudebush VA Medical Center

Phone: 317-988-4049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place