Trial Outcomes & Findings for Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM (NCT NCT01816230)

Last Updated: 2020-10-22

Results Overview

Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

36 participants

Primary outcome timeframe

42 days

Results posted on

2020-10-22

Participant milestones
Measure	NiCord® NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord®
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM

Baseline characteristics by cohort
Measure	NiCord® n=36 Participants NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic umbilical cord blood (UCB) cells. NiCord®
Age, Continuous	44 Years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Primary diagnosis Acute lymphoblastic leukemia (ALL)	9 Participants n=5 Participants
Primary diagnosis Adult acute myeloid leukemia (AML)	17 Participants n=5 Participants
Primary diagnosis Myelodysplastic syndromes (MDS)	7 Participants n=5 Participants
Primary diagnosis non-Hodgkins Lymphoma	0 Participants n=5 Participants
Primary diagnosis Hodgkins Disease	1 Participants n=5 Participants
Primary diagnosis Chronic myeloid leukemia (CML)	2 Participants n=5 Participants
Adjusted disease risk index Low	8 Participants n=5 Participants
Adjusted disease risk index Intermediate	15 Participants n=5 Participants
Adjusted disease risk index High	13 Participants n=5 Participants

Timeframe: 42 days

Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation.

Outcome measures
Measure	NiCord® n=36 Participants NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord®
Engraftment	94 percentage of patients

Serious events: 34 serious events

Other events: 36 other events

Deaths: 16 deaths

Serious adverse events
Measure	NiCord® n=36 participants at risk NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord®
Infections and infestations Infection	47.2% 17/36 • one year
Immune system disorders GvHD	30.6% 11/36 • one year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hematologic Malignancy	22.2% 8/36 • one year

Other adverse events
Measure	NiCord® n=36 participants at risk NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord®
Metabolism and nutrition disorders Decreased appetite	25.0% 9/36 • one year
Vascular disorders Hypertension	36.1% 13/36 • one year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia recurrent	13.9% 5/36 • one year
Metabolism and nutrition disorders Hyperglycemia	16.7% 6/36 • one year
Immune system disorders GvHD	16.7% 6/36 • one year

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