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Autologous Adoptive T Regulatory Cell Transfer in Autoimmune Diseases.

NCT05566977 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-05

No results posted yet for this study

Summary

Investigators aim to develop an effective and safe treatment of autoimmune diseases through adoptive T regulatory cells transfer. Our objectives are to evaluate the safety and efficacy of autologous adoptive Treg (CD4CD25FoxP3 CD127 low regulatory) cell transfer to patients with refractory autoimmune diseases: Refractory lupus Nephritis, and adults' type1 diabetes mellitus. Patients and Methods: This is Non randomized open label phase 1 pilot study including ten patients with refractory lupus nephritis and ten patients with Type 1 diabetic patients. All patients will be subjected to Full history taking, clinical examination and pretreatment investigations according to the type of autoimmune disease then regulatory T cells (Tregs) identification and count, Treg isolation and expansion and finally administration of T reg cells and follow-up of adverse events and outcomes.

Conditions

Interventions

OTHER

autologous adoptive T regulatory cell transfer.

Identification and count, using flowcytometry, for human Tregs will be based on both positive and negative cell markers, human Tregs are (CD4+, CD25+, CD127-, Foxp3+). Peripheral heparinized venous blood will be used .GMP-Compliant Protocol for the Isolation and Expansion of Tregs for Clinical Application .Cryopreservation of Expanded Tregs .Administration of T reg cells and follow-up of adverse events.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-08-31
Completion
2024-08-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566977 on ClinicalTrials.gov