Evidence map›Paper›PMID 35298656›Full record

Trial reportStem cells translational medicine2022

Phase I/IIa Feasibility Trial of Autologous Quality- and Quantity-Cultured Peripheral Blood Mononuclear Cell Therapy for Non-Healing Extremity Ulcers.

Rica Tanaka, Satoshi Fujimura, Makiko Kado, Taro Fukuta, Kayo Arita, Rie Hirano-Ito, Tomoya Mita, Hirotaka Watada, Yoshiteru Kato, Katsumi Miyauchi and 1 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Stem cells translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. The Efficacy of Stem Cells in Wound Healing: A Systematic Review.International journal of molecular sciences · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Rica TanakaDivision of Regenerative Therapy, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0002-6370-0915
Satoshi FujimuraDivision of Regenerative Therapy, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Makiko KadoDepartment of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Taro FukutaDepartment of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Kayo AritaDivision of Regenerative Therapy, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Rie Hirano-ItoDivision of Regenerative Therapy, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Tomoya MitaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-5961-1816
Yoshiteru KatoDepartment of Internal Medicine, Division of Cardiology, Juntendo University School of Medicine, Tokyo, Japan.
Katsumi MiyauchiDepartment of Internal Medicine, Division of Cardiology, Juntendo University School of Medicine, Tokyo, Japan.
Hiroshi MizunoDepartment of Plastic and Reconstructive Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Juntendo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Non-healing wounds are among the main causes of morbidity and mortality. We recently described a novel, serum-free ex vivo expansion system, the quantity and quality culture system (QQc), which uses peripheral blood mononuclear cells (PBMNCs) for effective and noninvasive regeneration of tissue and vasculature in murine and porcine models. In this prospective clinical study, we investigated the safety and efficacy of QQ-cultured peripheral blood mononuclear cell (MNC-QQ) therapy for chronic non-healing ischemic extremity wounds. Peripheral blood was collected from 9 patients with 10 chronic (>1 month) non-healing wounds (8 males, 1 female; 64-74 years) corresponding to ischemic extremity ulcers. PBMNCs were isolated and cultured using QQc. Within a 20-cm area surrounding the ulcer, 2 × 107 cells were injected under local anesthesia. Wound healing was monitored photometrically every 2 weeks. The primary endpoint was safety, whereas the secondary endpoint was efficacy at 12-week post-injection. All patients remained ambulant, and no deaths, other serious adverse events, or major amputations were observed for 12 weeks after cell transplantation. Six of the 10 cases showed complete wound closure with an average wound closure rate of 73.2% ± 40.1% at 12 weeks. MNC-QQ therapy increased vascular perfusion, skin perfusion pressure, and decreased pain intensity in all patients. These results indicate the feasibility and safety of MNC-QQ therapy in patients with chronic non-healing ischemic extremity wounds. As the therapy involves transplanting highly vasculogenic cells obtained from a small blood sample, it may be an effective and highly vasculogenic strategy for limb salvage.

Indexed as

Leukocytes, MononuclearUlcerExtremitiesFeasibility StudiesFemaleHumansIschemiaMaleProspective Studiesautologous stem cell transplantationclinical trialperipheral blood stem cellvascular development

Identifiers

PMID35298656
PMCPMC8929435
OpenAlexW4205643648

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.