THERAPY DOSSIER · th-068cd7498e99

Human placental derived 3D expanded adherent stromal cells, PLX-Mat (pure maternal) and PLX-RAD (mixed maternal and fetal)

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Radiation
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 9

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

NCT01525667 ↗Injury indicationPHASE1/PHASE2completed

Intramuscular allogeneic PLX-PAD cells for regeneration of injured gluteal musculature after total hip arthroplasty

Muscle Injury · Total Hip Arthroplasty

Enrolment: 20 · Results not recorded

NCT06678399 ↗Injury indicationPHASE1/PHASE2not yet recruiting

Allogeneic placental mesenchymal cells (KELI-101) for preemptive treatment of acute kidney injury risk after cardiac surgery

Acute Kidney Injury

Enrolment: 91 · Results not recorded

NCT03006770 ↗PHASE3completed

Intramuscular PLX-PAD for critical limb ischemia with minor tissue loss unsuitable for revascularisation

Critical Limb Ischemia

Enrolment: 213 · Results not recorded

NCT04652908 ↗PHASE1/PHASE2recruiting

Placental mesenchymal stem cells for repair of fetal myelomeningocele

Myelomeningocele

Enrolment: 55 · Results not recorded

NCT00919958 ↗PHASE1completed

Intramuscular injection of allogeneic PLX-PAD cells for critical limb ischemia

Critical Limb Ischemia · Peripheral Artery Disease

Enrolment: 15 · Results not recorded

NCT00951210 ↗PHASE1completed

Intramuscular injections of allogeneic PLX-PAD cells for critical limb ischemia

Critical Limb Ischemia · Peripheral Artery Disease

Enrolment: 12 · Results not recorded

NCT01795950 ↗PHASE1terminated

Intravenous infusion of PLX-PAD cells in patients with pulmonary arterial hypertension

Pulmonary Arterial Hypertension

Enrolment: 6 · Results not recorded

NCT03746899 ↗Phase not recordedavailable

Expanded access: intramuscular PLX-PAD for critical limb ischemia with minor tissue loss

Critical Limb Ischemia

Enrolment not recorded · Results not recorded

NCT05658094 ↗NAunknown

Placental mesenchymal stem cell-derived exosome for hair loss

Hair Loss · Alopecia

Enrolment: 20 · Results not recorded

Preclinical evidence 1

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

PMID 23823334 ↗2013Reported benefit

Mitigation of Lethal Radiation Syndrome in Mice by Intramuscular Injection of 3D Cultured Adherent Human Placental Stromal Cells.

MouseRadiationC3H/HeNMalen = Merged repeat experiments of 9 to 12 mice per arm; main sur…Intramuscular, into two sites in the thigh muscle of each hind limb2 million cells per injection in 100 microlitre given as 4…First injection 24 h after irradiation, with delayed start arms at 48 h or 72 h…

Model: Total body irradiation with a clinical 6 to 18 MeV linear accelerator; main survival model 7.7 Gy giving about 30 per cent control survival, with 6 Gy and 8.5 Gy arms and escalating doses for dose modifying factor estimation

PLX-RAD raised survival after 7.7 Gy from about 27 per cent in vehicle controls to 97 to 98 per cent, while PLX-Mat raised it to about 67 to 68 per cent, giving a dose modifying factor of about 1.22 to 1.23. Treated mice recovered weight, bone marrow cellularity, progenitor fraction and blood count…

Extraction: extract · Supplied extraction confidence: 0.9. Machine-extracted fields require source verification.

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