Suggested Patient Selection Criteria… | 2021

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43/100

✓ Peer-reviewed alzhub usefulness score 43 out of 100. Risk factors

Topic: Brain proteins, microglia and lab models

Plain-language summary

Chronic dialysis is associated with relatively high mortality and increased comorbidities that may render the patient unsuitable for renal transplantation. Life-supporting genetically modified pig kidney transplantation in nonhuman primates is currently associated with substantial success, with recipient survival extending for many months or even more than a year.12-17 It is therefore becoming important to determine which patients could be considered as potential recipients in the first clinical trials. (ii) The results of studies in the pig-to-nonhuman primate kidney transplant model will suggest that there is a realistic probability of achieving a clinically useful period of dialysis-free survival in a patient, for example, a minimum of 12 months and hopefully much longer. Significant comorbidities are likely to increase posttransplant morbidity or mortality. However, we suggest that the patients should have been initiated on chronic hemodialysis (and should not undergo preemptive kidney xenotransplantation, ie, before requiring dialysis) because the patient and his/her family should be convinced that kidney failure has progressed to the point where death would have occurred if dialysis had not been initiated. We also suggest that the patient should be of an age where it is unlikely that he/she will survive until a deceased donor becomes available. SELECTION OF PATIENTS FOR PIG KIDNEY XENOTRANSPLANTATION On the basis that the period on the waitlist might be so long that they may die before being allocated a deceased human donor organ, we have suggested that older age patients (55–60 y or possibly 55–65 y), but with good physiology and with no comorbidities, particularly of blood group O (as these patients tend to spend longer on the waitlist), should be considered as potential candidates for the first clinical trial.2 As the anticipated period of pig graft survival remains uncertain, younger patients, who are more likely to survive until a suitable allograft becomes available, should perhaps be excluded from the initial trials. CRP ≥8 mg/L (CRP levels ≥8 mg/L are consistently associated with increased risk of death of patients on chronic dialysis).27-29 Surgical contraindications No previous major abdominal surgical procedures that would complicate kidney transplantation CRP, C-reactive protein; MLR, mixed lymphocyte reaction; PBMC, peripheral blood mononuclear cell; RBC, red blood cells; TKO, triple-knockout. Importantly, information on median waiting t

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APA 7th

Jagdale, A., Kumar, V., Anderson, D. J., Locke, J. E., Hanaway, M. J., Eckhoff, D. E., et al. (2021). Suggested Patient Selection Criteria for Initial Clinical Trials of Pig Kidney Xenotransplantation in the United States. Transplantation. https://doi.org/10.1097/tp.0000000000003632

Vancouver

Jagdale A, Kumar V, Anderson DJ, Locke JE, Hanaway MJ, Eckhoff DE, et al. Suggested Patient Selection Criteria for Initial Clinical Trials of Pig Kidney Xenotransplantation in the United States. Transplantation. 2021. doi:10.1097/tp.0000000000003632. PMID: 33481554.

BibTeX

@article{jagdale2021-33481554,
  author  = {Jagdale, Abhijit and Kumar, Vineeta and Anderson, Douglas J. and Locke, Jayme E. and Hanaway, Michael J. and Eckhoff, Devin E. and Iwase, Hayato and Cooper, David K.C.},
  title   = {{Suggested Patient Selection Criteria for Initial Clinical Trials of Pig Kidney Xenotransplantation in the United States}},
  journal = {Transplantation},
  year    = {2021},
  doi     = {10.1097/tp.0000000000003632},
  pmid    = {33481554},
  url     = {https://doi.org/10.1097/tp.0000000000003632}
}

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How to read this study

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What the evidence grade means here

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Key findings

Chronic dialysis is associated with relatively high mortality and increased comorbidities that may render the patient unsuitable for renal transplantation.
Life-supporting genetically modified pig kidney transplantation in nonhuman primates is currently associated with substantial success, with recipient survival extending for many months or even more than a year.12-17 It is therefore becoming important to determine which patients could be considered as potential recipients in the first clinical trials.
(ii) The results of studies in the pig-to-nonhuman primate kidney transplant model will suggest that there is a realistic probability of achieving a clinically useful period of dialysis-free survival in a patient, for example, a minimum of 12 months and hopefully much longer.
Significant comorbidities are likely to increase posttransplant morbidity or mortality.
However, we suggest that the patients should have been initiated on chronic hemodialysis (and should not undergo preemptive kidney xenotransplantation, ie, before requiring dialysis) because the patient and his/her family should be convinced that kidney failure has progressed to the point where death would have occurred if dialysis had not been initiated.

Why it matters

This paper suggests patient selection criteria for initial clinical trials of pig kidney xenotransplantation in the United States. It notes that life-supporting genetically modified pig kidney transplantation in nonhuman primates is currently associated with substantial success, with recipient survival extending for many months or more than a year.

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Study details

Evidence strengthLow

How this study scored 43/100

Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomized / blinded because the record does not state it.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (Transplantation)
Journal's citation record	3 / 4	Transplantation: journal h-index 276 (OpenAlex, 2026-10-29)
Study design	0 / 12	No study design recorded — scores zero, not guessed (not stated in the record — scored 0)
Strength of evidence	1 / 5	Rated “low” in our summary
Peer-review validation	10 / 10	Peer-reviewed. Published as an article in a named peer-reviewed journal.
How recent	3 / 5	2021 — within 6 year(s) of the newest study here
Sample size	0 / 4	Participant count not stated — scores zero (not stated in the record — scored 0)
Effect reported	0 / 3	No effect size reported — scores zero (not stated in the record — scored 0)
Studied in people	0 / 3	Not stated whether this was studied in people — scores zero (not stated in the record — scored 0)
Randomized / blinded	0 / 2	No randomization or blinding stated — scores zero (not stated in the record — scored 0)
Times cited	4 / 7	Cited 43 times (OpenAlex, 2026-10-10)
Citations per year	2 / 5	6.1 citations a year over 7 year(s) since 2021
Impact for its field and year	3 / 6	Cited 6.2× the average for papers of its field and year (OpenAlex FWCI)
Cited by studies here	0 / 6	No other study in this library cites it
Still being cited	2 / 4	Cited 20 times in 2024–2026 (2026 still in progress; OpenAlex)
Senior author's track record	2 / 4	Last-listed author David K.C. Cooper: h-index 46 (OpenAlex, whole career)
Institution's track record	1 / 3	University of Alabama at Birmingham: institution h-index 1,118 (OpenAlex)
Multicenter collaboration	1 / 3	OpenAlex lists 2 institution(s) in 1 country
Indexed in PubMed	2 / 2	Indexed in PubMed (PMID 33481554)
Free to read	2 / 2	Free to read
Total	43 / 100	—

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Read the original

Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).

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