Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte) (CARDIOSTEM)

July 9, 2024 updated by: CellProthera

Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor for Validation of a Cell Expansion Automaton Allowing the Simultaneous Production of Several Cell Grafts for Therapeutic Use

Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell grafts for therapeutic use in the cardiac field - 2nd STAGE

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The rationale for the MHS002 study is based on the expansion results obtained with the first version of the machine (MHS001):

  • Average expansion rate of about 20-fold of CD34+ stem cells observed in a reproducible way on the Mulhouse and Créteil sites,
  • No significant difference in phenotypic, immunological or morphological characteristics between the "naive" cells (not multiplied) and the cells after multiplication, nor any chromosomal alteration or hyperploidy: the expansion process developed does not lead to any cellular modification,
  • Variability in the number of stem cells obtained after multiplication between healthy volunteers.

Developing a second generation prototype capable of producing 15 grafts per month, it is necessary to proceed with its biological validation, in the same way as the first generation prototype (protocol MHS001) was validated, following the requirements of regulatory agencies. Furthermore, in view of these results, it appeared necessary to define the lower limit of the number of CD34+ stem cells composing the graft, below which the therapeutic efficacy will be reduced or nil. This second stage of the study will make it possible to validate a potency test, i.e. a test making it possible to define the composition and potential effectiveness of the graft before its reinjection.

Given the absence of serious adverse events following the administration of G-CSF in healthy volunteers and in the context of the continued development of the second version of the automaton, validations similar to the first protocol are still necessary. Blood donation from healthy volunteers following stem cell mobilisation by G-CSF administration will allow validation of the second version.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • GHU La Pitié-Salpêtrière
        • Contact:
          • Joe-Elie SALEM, MD
      • Strasbourg, France, 67000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male volunteers,
  • Age ≥ 18 years and ≤ 60 years,
  • Agreeing to the collection of blood products by whole blood donation for scientific research purposes,
  • Fit for collection by the collecting physician after a medical examination including measurement of blood pressure, heart rate, electrocardiogram and assessment of venous potential,
  • Minimum weight: 50 kg,
  • Body mass index (BMI) < 30,
  • Haemoglobin level between 13 g/dL and 18 g/dL,
  • Platelet count between 150.106/mL and 400.106/mL
  • White blood cell count ≥ 3.9.106/mL with neutrophils ≥ 2.5.106/mL,
  • Agreement to be registered in the national research file,

Exclusion Criteria:

  • Any cardiopulmonary abnormality on initial clinical and ECG assessment
  • Clinical measurement of systolic BP ≤ 110 mmHg and/or diastolic BP < 70 mmHg on initial workup
  • Any blood work-up abnormality deemed significant by the investigator at the time of the initial work-up,
  • Previous administration of any haematopoietic growth factor,
  • Regular use of medication(s) within 8 days prior to the start of the Granocyte mobilisation phase,
  • Any significant cardiovascular history within the last 2 years
  • Any history of severe pulmonary disease (including bacterial or viral pneumonia)
  • Any history of cancer (solid tumours or haematological malignancies)
  • Anysevere neurological history
  • Any severe psychiatric history
  • Renal history (creatinine clearance from stage 1 to stage 5 of the HAS 2012 classification)
  • Twins with a living twin brother or sister,
  • Allergy to any of the excipients of Granocyte,
  • History of severe drug allergy, anaphylactic allergic shock or angioedema
  • Pre-existing splenomegaly
  • Obesity (BMI 30),
  • Autoimmune diseases,
  • Alcohol and drug abuse, drug abuse
  • Blood donation within 2 months prior to inclusion
  • Volunteer registered or wishing to register on the bone marrow donor list,
  • Sickle cell disease,
  • Presence of positive virological markers (anti HIV1 and 2, HTLV1 and 2, anti-HCV, anti-HBS, anti-HBC serologies), active syphilis,
  • Rheumatoid arthritis,
  • Anticoagulant therapy,
  • History of cutaneous vasculitis
  • Phenylketonuria,
  • Subject on exclusion from another study
  • Subject under administrative or judicial supervision
  • Subject who would receive more than 4500 euros in compensation due to participation in other research in the 12 months preceding this study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Sub cutaneous injection of Lenograstim with blood donation (450ML) after 4 days of mobilization
Drug: Lenograstim
Injection sub cutaneous of Lenograstim during 4 days, once per day
Other Names:
  • Granocyte(R)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of blood donation of CD34+ stem cells obtained to validate the new automaton
Time Frame: From day 0 of mobilization phase to day 5 corresponding to day of blood harvest
Validation of the second generation of the automaton able to expend CD34+ stem cells, by collection of 450 mL of blood containing CD34+ stem cells. Blood will be collected after 4 days of mobilization with haematopoietic growth factor (rhu-G-CSF = Granocyte)
From day 0 of mobilization phase to day 5 corresponding to day of blood harvest

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of CD34+ cells obtained with the second generation machine
Time Frame: From Day 0 to Day 9 expansion
Confirm that the number of CD34+ cells obtained with the "2nd generation" machine is equivalent to that obtained with the 1st generation machine
From Day 0 to Day 9 expansion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CellProthera

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Mutter, MD, CHRU Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-A01558-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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