HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies

This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institut Paoli Calmettes

Marseille, Bouches du Rhône, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
HLA-partially matched family donors
Affiliated to(or beneficiary of) the Social Security
Informed consent signed

Exclusion criteria

AML3
Previous Hematopoietic Stem Cell TRansplantation
Uncontrolled infection -PS>3 -Other progressive cancer
Psychiatric disease
Vulnerable person or unable to provide informed consent
Emergency
Unable to comply with required study follow up

Treatment and study plan

HLA-mismatched microtransplantation

Biological

3 administrations of hematopoietic stem cells without immunosupression

Primary outcomes

Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment

Time frame: 100 days after transplantation

Cumulative incidence of acute GVH (grade 1 to 4)

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: MICROSTEM

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Jul 27, 2017
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed