Obtaining an accepted Investigational New Drug application to operate an umbilical cord blood bank

Reems, Jo Ann; Fujita, Deanna; Tyler, Tom; Moldwin, Richard L.; Smith, Stephen

doi:10.1046/j.1537-2995.1999.39499235666.x

Cited by 7 publications

(3 citation statements)

References 10 publications

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“…All phases of umbilical cord blood (CB) banking (Rubinstein et al , 1993, 1994) are regulated by International and National Standards (Reems et al , 1999; Migliaccio et al , 2001; Warkentin, 2003). In particular, according to the Italian Group for Collection and Amplification of Hematopoietic Stem Cells (GRACE) standards, obstetrical criteria for CB collection included full‐term delivery, rupture of membranes <12 h, normal foetal development and absence of acute foetal distress (AFD).…”

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confidence: 99%

Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Picardi

Tamburini

Caravita

et al. 2006

Transfusion Medicine

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Clinical diagnosis of acute foetal distress (AFD) is based on several parameters such as abnormal foetal heart rate (FHR) pattern and/or meconium liquid staining (MLS). Standards for cord blood (CB) banking indicate that AFD should be considered as exclusion criteria for CB collection, but precise guidelines on how to proceed with CB collection in the presence of AFD signs during labour are not available. We evaluated whether the presence of FHR abnormality and/or MLS during labour 1) reduced the CB collection activity; 2) were associated with the infant's acidaemia or asphyxia and 3) deteriorated the biological characteristics of CB units. Thirty-three units of CB were evaluated for biological parameters, gas values and newborn's Apgar score. The results were compared with a control group of 33 consecutive units previously banked. No differences were observed between the two groups and all but one newborn showed normal Apgar score and absence of metabolic acidaemia. The results showed that 1) AFD reduced the CB collection activity by 10% each year; 2) the majority of CB units collected in the presence of abnormal FHR and/or meconium have biological characteristics eligible for banking; 3) FHR alterations or meconium in the presence of normal gas analysis do not represent certain diagnosis of AFD.

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confidence: 99%

Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Picardi

Tamburini

Caravita

et al. 2006

Transfusion Medicine

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“…Similar challenges were faced by the organ transplant community and the blood cell community and no doubt procedures can be adapted from processes developed by these groups. 16 However, as with any such adaptation process there will no doubt be unique issues that must be resolved.…”

Section: Scalable/gmp'able Processesmentioning

confidence: 99%

Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues

Rao¹

2007

Gene Ther

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Embryonic stem cells unlike most adult stem cell populations can replicate indefinitely while preserving genetic, epigenetic, mitochondrial and functional profiles. ESCs are therefore an excellent candidate cell type for providing a bank of cells for allogenic therapy and for introducing targeted genetic modifications for therapeutic intervention. This ability of prolonged self-renewal of stem cells and the unique advantages that this offers for gene therapy, discovery efforts, cell replacement, personalized medicine and other more direct applications requires the resolution of several important manufacturing, gene targeting and regulatory issues. In this review, we assess some of the advance made in developing scalable culture systems, improvement in vector design and gene insertion technology and the changing regulatory landscape.

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“…In this issue of TRANSFUSION , Reems et al 1 report on their experience with the process of applying for an Investigational New Drug (IND) application related to the operation of an umbilical cord blood bank. The IND process may not be familiar to many transfusion medicine practitioners, and this editorial will discuss some of the basic aspects of this regulatory mechanism.…”

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confidence: 99%

The IND: What is it and who needs it?

1999

Transfusion

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Obtaining an accepted Investigational New Drug application to operate an umbilical cord blood bank

Cited by 7 publications

References 10 publications

Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues

The IND: What is it and who needs it?

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