Autologous Adoptive T Regulatory Cell Transfer in Autoimmune Diseases.

NCT05566977 | Unknown Phase 1

• 1 other identifier: FMASU P19a/2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Lupus Nephritis; Type 1 Diabetes Mellitus

Keywords

T regulatory cells ,lupus nephritis ,type 1 diabetes .

Outcome Measures

Primary Outcomes (2)

• Safety of the adoptive T regs transfer

  percentage of patients who developed toxic adverse events

  4 weeks

• Efficacy of the adoptive T regs transfer

  Serum detection of INF-gama,TNF-alpha,IL1,IL2,TGF-beta,IL-10,IL-17

  44 weeks

Secondary Outcomes (1)

• Prevention or stop progression to organ failure

  44 weeks

Study Arms (1)

patients with autoimmune disease :lupus nephritis and type1 diabetes melitus

EXPERIMENTAL

single arm of patients with autoimmune diseases : patients of the first group selected as refractory lupus nephritis. patients of the second group of autoimmune diseases are selected to have type1 diabetes Meletus.

Other: autologous adoptive T regulatory cell transfer.

Interventions

autologous adoptive T regulatory cell transfer. OTHER

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.

patients with autoimmune disease :lupus nephritis and type1 diabetes melitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as refractory lupus nephritis .
• Hemoglobin level\> or equal 11g/dl before withdrawal of blood from patient to isolate T reg cells.
• Written informed consent from every patient before participation.

You may not qualify if:

• Diabetes mellitus
• End-stage renal disease.
• Pregnant and lactation.
• Patients on treatment by high-dose glucocorticoids more than 20 mg/day at the time of enrollment.
• Patients having psychiatric or neurological disease interfere with getting informed consent.
• Patients having fever, local or systemic infection at time of administration of adoptive T reg cells.
• Age less than or equal 18 years old.
• Patients with other autoimmune disease.
• Vitamin D deficient patients
• Group 2: type 1 diabetes Meletus
• Documented Autoimmune type 1 diabetes Meletus (TID) with disease duration ≤ 1 year, Anti GAD antibodies will be measured to all recruited patients to document autoimmunity.
• Age ≥ 18 years old.
• Fasting plasma C-peptide levels \>0.4 ng/mL.
• Patients on basal-bolus therapy
• HbA1c % ≤ 8%

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university, faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Zeinab Ashour, Professor

CONTACT

01096056735; zeinabashour2012@med.asu.edu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of internal medicine, allergy and clinical immunology

Model Details: refractory lupus nephritis type one diabetes in adults

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 5, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: October 5, 2022

Record last verified: 2022-09

Locations

EG (1)