Drugs / rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells
last change May 2026 re-read 9 days ago

rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells

targets CD40LG, CXCR4, CYBB, FANCA, IL2RG via restoration

Developed for
age-related macular degeneration · arteriosclerosis obliterans · chronic kidney disease · COVID-19 · Fanconi anemia · granulomatous disease, chronic, X-linked · HIV infectious disease · hyper-IgM syndrome type 1
+7 more · limb ischemia · myocardial ischemia · rotator cuff syndrome · T-B+ severe combined immunodeficiency due to gamma chain deficiency · thromboangiitis obliterans · WHIM syndrome · non-Hodgkin lymphoma
Investigated by
Lisata Therapeutics, Inc. · National Institute of Allergy and Infectious Diseases (NIAID) · Belarusian State Medical University · Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT) · Centro de Investigación en Red de Enfermedades Raras (CIBERER) · City of Hope Medical Center
+8 more · Hospital Infantil Universitario Niño Jesús, Madrid, Spain · Hospital Vall d'Hebron · Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · National Cancer Institute (NCI) · Second Affiliated Hospital, School of Medicine, Zhejiang University · Universitaire Ziekenhuizen KU Leuven · Universitat Autonoma de Barcelona

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07320378 May 2026 → Jun 2028 expected rotator cuff syndrome Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 13 trials
Phase 1 NCT04990427 Jan 2022 → Jan 2023 chronic kidney disease Lisata Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT04522817 Oct 2020 → May 2021 COVID-19 Lisata Therapeutics, Inc. Withdrawn No outcome recorded
Phase 1 NCT02337985 Nov 2015 → Aug 2027 expected Burkitt lymphoma, HIV infectious disease, plasmablastic lymphoma, primary effusion lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1/26 trials · 1 met primary
Phase 1/2 NCT07775313 Oct 2026 → Dec 2031 expected WHIM syndrome, dysgammaglobulinemia, myeloid hemopathy, skin disorder caused by infection National Institute of Allergy and Infectious Diseases (NIAID) Enrolling by invitation No outcome recorded
Phase 1/2 NCT06959771 Jul 2025 → Oct 2027 expected hyper-IgM syndrome type 1 National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1/2 NCT06851767 May 2025 → Dec 2034 expected T-B+ severe combined immunodeficiency due to gamma chain deficiency National Institute of Allergy and Infectious Diseases (NIAID) Enrolling by invitation No outcome recorded
Phase 1/2 NCT06325709 Apr 2024 → Dec 2032 expected granulomatous disease, chronic, X-linked National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 1/2 NCT05187104 Mar 2022 → Dec 2023 age-related macular degeneration Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Unknown No outcome recorded
Phase 1/2 NCT03157804 Jan 2016 → Apr 2019 Fanconi anemia Hospital Infantil Universitario Niño Jesús, Madrid, Spain Completed Met primary
Phase 22 trials · 1 met primary
Phase 2 NCT02501018 Nov 2017 → May 2022 arteriosclerosis obliterans, limb ischemia, thromboangiitis obliterans Lisata Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT00300053 Apr 2006 → Mar 2008 myocardial ischemia Lisata Therapeutics, Inc. Completed Met primary
Phase 31 trial
Phase 3 NCT02437708 Sep 2014 → Aug 2019 — Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2022-05-19 Lisata Therapeutics, Inc. Results Caladrius Biosciences Announces IDMC Recommendation to Advance CLBS201 Trial for the Treatment of Diabetic Kidney Disease lisata.com ↗
Based on their assessment of the data, the IDMC approved proceeding with the enrollment of the remaining four patients in the study without further review.
2021-06-22 Lisata Therapeutics, Inc. Regulatory Caladrius Biosciences to Assess its CLBS201 CD34+ Cell Therapy in Diabetic Kidney Disease lisata.com ↗
FDA authorizes new IND for the study of CLBS201 in patients with reduced kidney function
2021-03-08 Lisata Therapeutics, Inc. Regulatory Caladrius Biosciences Announces Orphan Drug Designation for CLBS12 for the Treatment of Buerger’s Disease lisata.com ↗
We are very pleased that the FDA has granted orphan drug designation to CLBS12 in Buerger’s disease.
2020-04-23 Lisata Therapeutics, Inc. Regulatory Caladrius Biosciences Plans to Assess its CLBS119 Cell Therapy for Repair of COVID-19 Induced Lung Damage lisata.com ↗
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, disease today announced that the U.S. Food and Drug Administration (“FDA”) has authorized its investigational new drug (“IND”) application for the study of CLBS119, a CD34+ cell therapy for repair of COVID-19 induced lung damage.

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells ClinicalTrials.gov intervention name — accepted as the source's own label NCT02337985 ↗
Known as Base-edited hematopoietic stem and progenitor cells ClinicalTrials.gov intervention name — accepted as the source's own label NCT06325709 ↗
3

NCT06959771 ↗

NCT06851767 ↗

NCT07775313 ↗

Known as CLBS119 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04522817 ↗
Known as CLBS12 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02501018 ↗
Known as CLBS14 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00300053 ↗
Known as CLBS201 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04990427 ↗
Known as Cultured retinal stem and progenitor cells ClinicalTrials.gov intervention name — accepted as the source's own label NCT05187104 ↗
Known as Genetically Engineered Hematopoietic Stem/Progenitor Cells ClinicalTrials.gov intervention name — accepted as the source's own label NCT03157804 ↗
Known as stem and progenitor cells ClinicalTrials.gov intervention name — accepted as the source's own label NCT02437708 ↗
Known as Tendon stem/progenitor cells “Therefore, this study intends to first culture and expand tendon stem/progenitor cells (TSPCs) to form therapeutic agents, then apply TSPC-enhanced therapy intraoperatively to...” NCT07320378 ↗
Known as TSPCs “Therefore, this study intends to first culture and expand tendon stem/progenitor cells (TSPCs) to form therapeutic agents, then apply TSPC-enhanced therapy intraoperatively to...” NCT07320378 ↗
Action Restore “in order to restore their hematopoiesis with genetically corrected stem cells” NCT03157804 ↗
Modality Cell therapy “Autologous CD34+ cell therapy was associated with persistent improvement in angina at 2 years” PMID 27151378 ↗ May 2016
Route Other “Autologous CD34+ cells will be delivered in 10 intramyocardial injections” NCT00300053 ↗
Target FANCA “lentiviral vector carrying the gene FANCA” NCT03157804 ↗