Kırılganlık Tedavisinde Mezenkimal Kök/Stromal Hücre Terapisi

Sade dilde özet

Bu çalışma, kırılganlık (frailty) durumu olan kişilerde göbek kordonu mezenkimal kök hücre nakli (umbilical cord mesenchymal stem cells transplantation) ile standart tedavinin birlikte kullanımını incelemektedir. Fried Fenotip Ölçeği'ne göre kırılganlık belirtileri gösteren (skor 3 ve üzeri) kişiler katılabilmektedir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Müdahale

Umbilical Cord Mesenchymal Stem Cells transplantation, standard frailty treatment and supplementary medication

Başlangıç

19.10.2021

Tahmini bitiş

30.12.2024

Ülkeler

Vietnam

İlgili genler

Merkezler

• Hanoi, Vietnam

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Must show signs of frailty apart from a concomitant condition as assessed by the investigator with a frailty score \>=3 using the Fried Phenotype Scale.
* They showed the signs of frailty based on physician assessment, apart from a concomitant condition, by a score between 3 and 6 as denoted by the Canadian Study on Health Aging.
* Must provide written informed consent.

Exclusion Criteria:

* Score of less than or equal to 20 on the Mini-Mental State Examination (MMSE)
* Active listing (or expected future listing) for transplant of any organ.
* Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin \<8 g/dl, white blood cell count \<3000/mm3, platelets\<80,000/mm3, alkaline phosphatase \> 3 times the upper limit of normal, total bilirubin \> 1.5 mg/dl.
* Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to HIV, advanced liver or renal failure, class II/III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilator defect, COPD with GOLD D, ischemic stroke with NIHSS \<5, type II diabetes with HbA1C \>8.5%
* Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
* Be an organ transplant recipient.
* Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease-free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.
* Have a non-pulmonary condition that limits lifespan to \< 1 year.