Wharton Jelly Mesenchymal Stromal Cells as GVHD Prophylaxis

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help prevent graft-versus-host disease (GvHD) in patients undergoing a specific type of stem cell transplant. GvHD is a condition that can occur when donor cells attack the recipient's body. The trial will use special cells called Wharton Jelly Mesenchymal Stem Cells (WJ-MSCs) during the transplant process to see if they can help reduce the risk of GvHD and support faster recovery of the blood system.

To be eligible for this trial, participants need to have certain types of blood cancers and must not have a matched sibling donor available. They should also be in good enough health to tolerate the treatment, which may involve high doses of a chemotherapy drug. Participants will receive weekly infusions of these special cells after their transplant to monitor how well they work. This trial is currently not recruiting participants, but it aims to find the safest dose of WJ-MSCs to help improve outcomes for patients undergoing this type of treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • With AML/ALL/SMD/SMP or lymphoid neoplasm requiring allogeneic stem cell transplantation
• • In complete response (CR) for AML/ALL or CR,partial response (PR) or non pre-treated for SMD/SMP and lymphoid neoplasm
• • Without a HLA matched related donor available and with identification of a haploidentical donor (brother, sister, parents, adult children or cousin)
• With usual criteria for HSCT:
• • ECOG ≤ 2
• • No severe and uncontrolled infection
• • Cardiac function compatible with high dose of cyclophosphamide
• • Adequate organ function: ASAT and ALAT ≤ 2N, total bilirubin ≤ 1.5N, creatinine clearance ≥30ml/min (except if those abnormalities are linked to the hematological disease)
• * Requiring a RIC or non myeloablative conditioning:
• • (i) \>50 years old; (ii) heavily pre-treated; (iii) Comoribidities according to Sorror et al. Blood 2005;106(8):2912-9, notamment HCT/CI≥ 3 (JAMA. 2011 Nov 2;306(17):1874-83).
• • With health insurance coverage (bénéficiaire ou ayant droit)
• • Understand informed consent or optimal treatment and follow-up
• • Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment and within 12 months for women of childbearing age and 6 months for men of childbearing age after the last dose of cyclophosphamide
• Exclusion Criteria:
• • History of Cancer in the last 5 years
• • Uncontrolled infection: Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR HBV or HCV and hepatic cytolysis due to HBV
• • Uncontrolled coronary insufficiency, recent myocardial infarction \<6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \<50%
• • Pulmonary failure with DLCO\<50%
• • Addition of immunosuppressant treatment for GVHD prophylaxis (except immunosuppressant allowed per protocol)
• • Renal failure with creatinine clearance \<50ml / min
• • Pregnancy (β-HCG positive) or breast-feeding
• • Any debilitating medical or psychiatric illness which would preclude the realization of the SCT or the understanding of the protocol
• • Under protection by law (tutorship or curatorship)
• • Unwilling or unable to comply with the protocol