Long term follow up for patients who have received NiCord/CordIn, stem cells from donated umbilical cord blood that were grown in a laboratory to expand their number

Long Term Follow Up for Patients who have received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004813-26-ES

Enrollment

Registered

2016-02-03

Start date

2016-03-14

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High risk haematological malignancies Hemoglobinopathies MedDRA version: 18.1 Level: LLT Classification code 10025316 Term: Lymphoma NOS System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10054658 Term: Thalas

Interventions

Product Name: NiCord(CF cultured fraction and NF non-cultured fraction) Pharmaceutical Form: Suspension for injection INN or Proposed INN: allogeneic, umbilical cord blood-derived, ex vivo expanded, h

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Anyone who has received a NiCord/CordIn transplant, signed the consent for this study, and completed study specific follow up. Are the trial subjects under 18? yes Number of subjects for this age range: 31 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A patient is not eligible if during the NiCord/CordIn transplant protocol, any of the following occurred before or on the completion of the last study visit (d365): Disease relapse/progression Autologous Recovery Graft Failure

Design outcomes

Primary

Measure	Time frame
Main Objective: Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation;Secondary Objective: Describe long term sustained engraftment of NiCord/CordIn transplantation Describe survival and disease free survival in NiCord/CordIn infused patients Describe characteristics of patients with secondary graft failure or disease relapse Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn Describe incidence of chronic GvHD ;Primary end point(s): Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation ;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows: Visit #1: 2 years post NiCord/CordIn infusion Visit #2: 3 years post NiCord/CordIn infusion Visit #3: 4 years post NiCord/CordIn infusion Visit #4: 5 years post NiCord/CordIn infusion	—

Measure

Time frame

Main Objective: Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation;Secondary Objective: Describe long term sustained engraftment of NiCord/CordIn transplantation Describe survival and disease free survival in NiCord/CordIn infused patients Describe characteristics of patients with secondary graft failure or disease relapse Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn Describe incidence of chronic GvHD ;Primary end point(s): Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation ;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows: Visit #1: 2 years post NiCord/CordIn infusion Visit #2: 3 years post NiCord/CordIn infusion Visit #3: 4 years post NiCord/CordIn infusion Visit #4: 5 years post NiCord/CordIn infusion

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Secondary

Measure	Time frame
Secondary end point(s): - Describe long term sustained engraftment of NiCord/CordIn transplantation - Describe survival and disease free survival in NiCord /CordIn infused patients - Describe characteristics of patients with secondary graft failure or disease relapse -Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn -Describe incidence of chronic GvHD ;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows: Visit #1: 2 years post NiCord/CordIn infusion Visit #2: 3 years post NiCord/CordIn infusion Visit #3: 4 years post NiCord/CordIn infusion Visit #4: 5 years post NiCord/CordIn infusion	—

Measure

Time frame

Secondary end point(s): - Describe long term sustained engraftment of NiCord/CordIn transplantation - Describe survival and disease free survival in NiCord /CordIn infused patients - Describe characteristics of patients with secondary graft failure or disease relapse -Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn -Describe incidence of chronic GvHD ;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows: Visit #1: 2 years post NiCord/CordIn infusion Visit #2: 3 years post NiCord/CordIn infusion Visit #3: 4 years post NiCord/CordIn infusion Visit #4: 5 years post NiCord/CordIn infusion

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Countries

Spain, United States

Contacts

Public ContactClinical Trial department

Gamida Cell Ltd

97226595666

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026