THERAPY DOSSIER · th-6270b38b245f

Human bone marrow stromal cells (hMSCs)

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: TBI
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 4

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

NCT02448849 ↗Injury indicationPHASE2/PHASE3unknown

Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial

Bone Fracture

Enrolment: 60 · Results not recorded

NCT01557543 ↗PHASE1terminated

Preliminary Assessment of Direct Intra-Myocardial Injection of Autologous Bone Marrow-derived Stromal Cells on Patients Undergoing Revascularization for CAD With Depressed Left Ventricular Function

Heart Disease · Ischemic Heart Disease · Coronary Artery Disease · Coronary Artery Disease (CAD)

Enrolment: 24 · Results not recorded

NCT01851343 ↗PHASE1terminated

An Open-Label, Phase 1 Study to Assess the Safety and Tolerability of Bone Marrow Stromal Cell Infusion for the Treatment of Moderate to Severe Inflammatory Bowel Disease

Inflammatory Bowel Disease

Enrolment: 8 · Results not recorded

NCT01686139 ↗PHASE1unknown

Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)

Type I Diabetes Mellitus With Ulcer · Type II Diabetes Mellitus With Ulcer

Enrolment: 12 · Results not recorded

Preclinical evidence 3

3 studies reported at therapy level; 3 evidence entries itemised.

PMID 28899758 ↗2017Reported benefit

Chronic global analysis of vascular permeability and cerebral blood flow after bone marrow stromal cell treatment of traumatic brain injury in the rat: A long-term MRI study.

RatTBIControlled cortical impactWistarMalen = 30 male Wistar rats: 6 h cell n=10, 1 week cell n=10, 6 h s…Intravenous, tail veinApproximately 3 x 10 to the power n hMSCs suspended in 1 ml…6 hours or 1 week after injury

Model: Controlled cortical impact to the left cortex, single impact at 4 m/s, 2.5 mm depth below dura, 6 mm diameter tip, after bilateral 10 mm craniotomies

Both cell-treated groups showed faster reduction of Ki and better spatial memory performance than saline. Acute (6 h) transplantation gave significantly lower Ki at 2 and 3 months and higher cerebral blood flow at 2 months versus saline, whereas delayed (1 week) treatment was less potent. Lesion vo…

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PMID 22781331 ↗2012Reported benefit

MRI measurement of angiogenesis and the therapeutic effect of acute marrow stromal cell administration on traumatic brain injury.

RatTBIControlled cortical impactWistarMalen = n = 18 total; saline n = 9, hMSC n = 9Intravenous injection3 x 10(6) hMSCs in 1 mL suspension6 hours after traumatic brain injury

Model: Controlled cortical impact traumatic brain injury

Transplantation of hMSCs 6 hours after injury reduced cerebral atrophy, produced earlier and enhanced cerebral tissue perfusion, increased angiogenesis and improved functional outcome relative to saline controls.

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PMID 22673246 ↗2012Mixed findings

The severity of brain damage determines bone marrow stromal cell therapy efficacy in a traumatic brain injury model.

RatTBIWeight-drop / impact-accelerationWistarFemaleIntracerebral injection into injured brain tissueTwo months after injury

Model: Weight-drop impact traumatic brain injury, chronically established (treated 2 months after injury)

Significant functional improvement was seen when BMSC were injected into animals with moderate brain damage, but no significant improvement was found in animals with severe functional deficits compared with controls, suggesting injury severity determines cell therapy efficacy in chronically establi…

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