Allogeneic adipose tissue-derived Mesenchymal stromal cells for the treatment of chronic-active antibody mediated rejection in Kidney transplant recipients (MY-KIDNEY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-03-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The main objective of this trial is to assess safety, feasibility, immunomodulatory and kidney protective effects of intravenous allogeneic MSC therapy in renal transplant recipients with c-aABMR.

Conditions and MedDRA coding

Chronic active antibody mediated rejection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. A. Biopsy proven diagnosis of ca-ABMR according to Banff 2017 with following 3 criteria: 1) Morphologic evidence of chronic tissue injury 2) Current/recent antibody interaction with vascular endothelium 3) Serologic evidence of circulating DSA to HLA. B. Age between 18 and 75 years of age. C. Renal transplant recipient first or repeat at least 6 months prior to screening. D. eGFR > 20 ml/min. E. Written, informed consent prior to study inclusion. F. If female and child-bearing potential, subject must be non-pregnant, non-breastfeeding and use adequate contraception.

Exclusion criteria 1

1. a. Multiorgan transplant recipient except for simultaneous kidney-pancreas or previous multiple renal transplants or cell transplants (islet or bone marrow). b. Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks prior to inclusion. c. Except for steroids, other treatments for ABMR or TCMR are not allowed within 3 months prior to the start of screening. d. On dialysis or expected to commence on dialysis within 3 months of inclusion. e. Evidence of active bacterial or viral infection, (except for an uncomplicated urinary tract infection) (e.g., CMV, Pneumocystis carinii (PCP), HIV, hepatitis B/C, aspergillosis, histoplasmosis, or mycobacteria). f. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. g. Use of any current investigational drug. h. Malignancy (including lymphoproliferative disease) within the past 2 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). i. Unwilling or unable to adhere to study requirements and procedures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy

Secondary endpoints 1

1. 1. Kidney function assessment: change in eGFR from before MSC infusion to after. 2. Chronic kidney rejection/damage assessment: change in kidney biopsy/histology, imaging and urinary findings from before MSC infusion to after. 3. Adverse events assessment: number of grade 3 or higher AEs attributable to MSC infusion 4. Anti-donor immune response assessments: changes in DSAs, immune cells and inflammation markers from before MSC infusion to after. 5.Opportunistic infection assessment: changes in

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Palle Juul-Jensens Boulevard 99

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Lara Aygen Øzbay

Public contact point

Organisation

Region Midtjylland

Contact name

Nyresygdomme Aarhus Universitetshospital

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications