Evidence map›Paper›PMID 31426803›Full record

Trial reportJournal of translational medicine2019

First-in-human study of TK-positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells.

Boris R Minev, Elliot Lander, John F Feller, Mark Berman, Bernadette M Greenwood, Ivelina Minev, Antonio F Santidrian, Duong Nguyen, Dobrin Draganov, Mehmet O Killinc and 7 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.6field-weighted citation impact, top 7% 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

24 citing papers in PubMed, 38 citations in OpenAlex.

  1. Article
  2. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
    Review
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  12. PRO-Simat: Protein network simulation and design tool.Computational and structural biotechnology journal · 2023
    Article
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  16. Intracranial Virotherapy for a Canine Hemangioma.International journal of molecular sciences · 2022
    Article
  17. Oncolytic viral vectors in the era of diversified cancer therapy: from preclinical to clinical.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
    Review
  18. Article
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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

17 authors at 9 institutions in 2 countries.

Boris R MinevCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA. bminev@calidibio.com.ORCID 0000-0003-0758-7177
Elliot LanderCell Surgical Network, Beverly Hills, USA.
John F FellerDesert Medical Imaging, Palm Desert, USA.
Mark BermanCell Surgical Network, Beverly Hills, USA.
Bernadette M GreenwoodDesert Medical Imaging, Palm Desert, USA.
Ivelina MinevCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Antonio F SantidrianCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Duong NguyenCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Dobrin DraganovCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Mehmet O KillincCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Anna VyalkovaInstitute of Biochemistry, University of Wurzburg, Würzburg, Germany.
Santosh KesariDepartment of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Santa Monica, USA.
Edward McClayCalifornia Cancer Associates for Research and Excellence, San Diego, USA.
Gabriel CarabuleaOcean View Hematology and Oncology Medical Group, San Clemente, USA.
Francesco M MarincolaRefuge Biotechnologies, Menlo Park, CA, USA.
Lisa H ButterfieldUniversity of Pittsburgh, UPMC Hillman Cancer Center, Pittsburgh, USA.
Aladar A SzalayCalidi Biotherapeutics, 10210 Campus Point Drive, Suite 150, San Diego, CA, 92121, USA.
Multimeric Biotherapeutics (United States) · USDesert Medical Imaging · USPancreatic Cancer Action Network · USUniversity of Würzburg · DECalifornia Cancer Associates for Research and Excellence · USRefuge Biotechnologies (United States) · USSaint John's Health Center · USUniversity of California San Diego · USUPMC Hillman Cancer Center · US

Funding

RPCI-UPCI Ovarian Cancer SPOREP50CA159981 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI MOYSICH, KIRSTEN B., ODUNSI, KUNLE · 2013 to 2025
$19.6M
NCI NIH HHS P50 CA159981
6 · The paper itself

Abstract

backgroundACAM2000, a thymidine kinase (TK)-positive strain of vaccinia virus, is the current smallpox vaccine in the US. Preclinical testing demonstrated potent oncolytic activity of ACAM2000 against several tumor types. This Phase I clinical trial of ACAM2000 delivered by autologous adipose stromal vascular fraction (SVF) cells was conducted to determine the safety and feasibility of such a treatment in patients with advanced solid tumors or acute myeloid leukemia (AML).

methodsTwenty-four patients with solid tumors and two patients with AML participated in this open-label, non-randomized dose-escalation trial. All patients were treated with SVF derived from autologous fat and incubated for 15 min to 1 h with ACAM2000 before application. Six patients received systemic intravenous application only, one patient received intra-tumoral application only, 15 patients received combination intravenous with intra-tumoral deployment, 3 patients received intravenous and intra-peritoneal injection and 1 patient received intravenous, intra-tumoral and intra-peritoneal injections. Safety at each dose level of ACAM2000 (1.4 × 10

resultsNo serious toxicities (> grade 2) were reported. Seven patients reported an adverse event (AE) in this study: self-limiting skin rashes, lasting 7 to 18 days-an expected adverse reaction to ACAM2000. No AEs leading to study discontinuation were reported. Viral DNA was detected in all patients' blood samples immediately following treatment. Interestingly, in 8 patients viral DNA disappeared 1 day and re-appeared 1 week post treatment, suggesting active viral replication at tumor sites, and correlating with longer survival of these patients. No major increase in cytokine levels or correlation between cytokine levels and skin rashes was noted. We were able to assess some initial efficacy signals, especially when the ACAM2000/SVF treatment was combined with checkpoint inhibition.

conclusionsTreatment with ACAM2000/SVF in patients with advanced solid tumors or AML is safe and well tolerated, and several patients had signals of an anticancer effect. These promising initial clinical results merit further investigation of therapeutic utility. Trial registration Retrospectively registered (ISRCTN#10201650) on October 22, 2018.

Indexed as

Adipose TissueAdultAgedAged, 80 and overCell Line, TumorDNA, ViralFemaleHumansKaplan-Meier EstimateMaleMiddle AgedOncolytic VirotherapyOncolytic VirusesStromal CellsThymidine KinaseTreatment OutcomeDNA, ViralThymidine KinaseClinical trialImmunotherapy of cancerOncolytic vaccinia virusStromal vascular fraction

Identifiers

PMID31426803
PMCPMC6699108
OpenAlexW2969839379

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.