THERAPY DOSSIER · th-e573d2c13f93

Keratinocyte growth factor gene-engineered mesenchymal stem cells

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Endotoxin/LPS
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: KGF-MSC; FGF7-engineered MSC
Note: Not recorded

Clinical trials 10

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT05139004 ↗Injury indicationPHASE1active not recruiting

90Y-DOTA-anti-CD25 added to conditioning for allogeneic HCT (palifermin included)

Acute Lymphoblastic Leukemia · Acute Myeloid Leukemia · Myelodysplastic Syndrome

Enrolment: 7 · Results not recorded

NCT00360971 ↗PHASE3terminated

Palifermin for reduction of oral mucositis in locally advanced head and neck cancer

Head and Neck Cancer · Mucositis · Radiation Toxicity

Enrolment: 21 · Results not recorded

NCT01386151 ↗PHASE2completed

Safety and efficacy of parenteral KGF in moderate asthmatic subjects

Bronchial Asthma

Enrolment: 24 · Results not recorded

NCT02961816 ↗PHASE2withdrawn

Panobinostat with high-dose GemBuMel and autologous SCT in relapsed lymphoma (palifermin included)

Lymphoma

Enrolment: 0 · Results not recorded

NCT00540332 ↗PHASE1/PHASE2withdrawn

Weekly palifermin (rHuKGF) for oral mucositis in head and neck cancer

Head and Neck Cancer

Enrolment: 0 · Results not recorded

NCT03315078 ↗PHASE1/PHASE2unknown

Lentiviral gene transfer for X-linked SCID (palifermin as conditioning adjunct)

X-Linked Combined Immunodeficiency Diseases

Enrolment: 13 · Results not recorded

NCT00070616 ↗PHASE1completed

PK of recombinant human keratinocyte growth factor (palifermin) in haematologic malignancies

Leukemia · Lymphoma · Myeloma

Enrolment: 25 · Results not recorded

NCT00361348 ↗PHASE1completed

Effect of heparin on palifermin PK and of palifermin on heparin PD in healthy subjects

Healthy Volunteers

Enrolment: 45 · Results not recorded

NCT00881556 ↗EARLY_PHASE1terminated

Reduced intensity conditioning and alloSCT in recessive dystrophic epidermolysis bullosa

Epidermolysis Bullosa

Enrolment: 3 · Results not recorded

NCT01233921 ↗NAcompleted

Palifermin in patients at risk of chronic graft-versus-host disease

Graft Versus Host Disease

Enrolment: 6 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 24367590 ↗2013Reported benefit

Keratinocyte growth factor gene delivery via mesenchymal stem cells protects against lipopolysaccharide-induced acute lung injury in mice.

MouseEndotoxin/LPSC57BL/6 (mesenchymal stem cell donors were 2-week-old male C57BL/6, cells used at passages 4 to 6 after lentiviral transduction at MOI 20)Malen = n=5 per group per assay set; survival study 40 mice randomi…Intravenous via the tail vein; lipopolysaccharide given intratracheally2 hours after lipopolysaccharide

Model: Intratracheal Escherichia coli O55:B5 lipopolysaccharide at 10 mg/kg under pentobarbital anaesthesia (90 mg/kg)

Keratinocyte growth factor engineered cells reduced the lung wet to dry ratio and lavage protein (P<0.01 versus saline), lowered neutrophils, myeloperoxidase, TNF-alpha and IL-1 beta, raised IL-10, and reduced the 72 hour lung injury score to 7.9 plus or minus 2.14 versus 12.73 plus or minus 2.42 f…

Extraction: extract · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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