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A Phase 1 Trial of a Single ProHema® CB Product for Pediatric Patients With Hematologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354417
Recruitment Status : Terminated
First Posted : February 3, 2015
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hematologic Malignancies
Intervention Biological: Biological: ProHema-CB
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ProHema-CB
Hide Arm/Group Description

All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.

ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:

For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.

For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.

Biological: ProHema-CB: Each subject will receive o

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title ProHema-CB
Hide Arm/Group Description

All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.

ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:

For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.

For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.

Biological: ProHema-CB: Each subject will receive one administration of ProHema-CB unit transplant.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
15.7  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
2
  66.7%
Not Hispanic or Latino
1
  33.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
1
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 3 participants
73.4  (28.8)
1.Primary Outcome
Title Safety Profile, Primarily Assessed by Neutrophil Engraftment
Hide Description To describe the safety profile of ProHema-CB after myeloablative conditioning in pediatric patients with hematologic malignancies. The safety profile will primarily be assessed by neutrophil engraftment.
Time Frame Neutrophil engraftment by Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ProHema-CB
Hide Arm/Group Description:

All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.

ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:

For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.

For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.

Biological: ProHema-CB: Each subject will receive one administration of ProHema-CB unit transplant.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
Time Frame During the First Year of Transplant
Adverse Event Reporting Description Serious Adverse Events and Adverse Events assessed as possibly or probably related to ProHema are included below.
 
Arm/Group Title ProHema-CB
Hide Arm/Group Description

All subjects will receive treatment with ProHema-CB (ex-vivo modulated human cord blood cells) transplant.

ProHema-CB (the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 also referred to as FT1050) will be prepared and administered in one of two formulations, based upon subject weight:

For subjects > 35 kg, ProHema-CB will be administered as 150 mL product in a blood bag via gravity infusion. It will be infused at 10 mL to 15 mL per minute, for a total infusion time of 10 to 15 min.

For subject's ≤ 35 kg, ProHema-CB will be administered as a 50 mL product in a syringe via syringe pump.o It will be infused at 5 mL/kg per hour for a total infusion time of up to ~1 hour.

Biological: ProHema-CB: Each subject will receive o

All-Cause Mortality
ProHema-CB
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Serious Adverse Events
ProHema-CB
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ProHema-CB
Affected / at Risk (%)
Total   2/3 (66.67%) 
General disorders   
Mucosal inflammation  1  1/3 (33.33%) 
Vascular disorders   
Hypertension  1  1/3 (33.33%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chris Storgard, Chief Medical Officer
Organization: Fate Therapeutics, Inc.
Phone: 866-875-1833
EMail: chris.storgard@fatetherapeutics.com
Layout table for additonal information
Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT02354417    
Other Study ID Numbers: FT1050-04
First Submitted: September 25, 2014
First Posted: February 3, 2015
Results First Submitted: February 28, 2018
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018