Mesenchymal stromal cells for the treatment of acute graft versus host disease

Mesenchymal stromal cells in patients with steroid refractory acute graft versus host disease after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18091201

Enrollment

Registered

2017-08-18

Start date

2013-10-09

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid refractory acute graft versus host disease after hematopoietic stem cell transplantation or donor lymphocyte infusion Injury, Occupational Diseases, Poisoning Bone-marrow transplant rejection

Interventions

Patients with steroid refractory acute graft versus host disease were treated with mesenchymal stromal cells as compassionate use medicinal product (standard of care). Doses have not been predetermine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Steroid refractory acute graft versus host disease after hematopoietic stem cell transplantation 2. 18 years old and older 3. Signed informed consent form

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR) to mesenchymal stromal cells, defined as complete response (CR) or partial response (PR) of acute graft versus host disease, measured at D7, D14, D21, D28, D35, D42, D49, D56, 3 months	—

Secondary

Measure	Time frame
Measured at D7, D14, D21, D28, D35, D42, D49, D56, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and each year thereafter: 1. Overall survival (OS), defined as time from the start of treatment until death from any cause 2. Event free survival, defined as time from the start of treatment until the following events (whichever occurs first): death, hematologic malignancy relapse, no PR/CR by 3 months since the study entry, aGVHD relapse after PR/CR requiring next line treatment, progression to extensive chronic GVHD	—

Measure

Time frame

Measured at D7, D14, D21, D28, D35, D42, D49, D56, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and each year thereafter: 1. Overall survival (OS), defined as time from the start of treatment until death from any cause 2. Event free survival, defined as time from the start of treatment until the following events (whichever occurs first): death, hematologic malignancy relapse, no PR/CR by 3 months since the study entry, aGVHD relapse after PR/CR requiring next line treatment, progression to extensive chronic GVHD

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Countries

Lithuania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026