Using fat-derived stem cells to treat chronic kidney disease
Evaluation of Therapeutic Potential of Stromal Vascular Fraction (Autologous Adipose Derived Mesenchymal Stem Cell) Based Treatment for Chronic Kidney Disease
This study is testing whether injecting fat-derived stem cells can help people with advanced chronic kidney disease feel better and slow down the progression of their condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Bangladesh Laser & Cell Surgery Institute & Hospital Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT03939741 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of injecting stromal vascular fraction containing autologous non-expanded adipose-derived stem cells in patients with chronic kidney disease (CKD). The study targets individuals with CKD stages 3 to 5, assessing how this innovative therapy may slow disease progression and improve kidney function. Participants will be closely monitored for any adverse effects and overall health outcomes following the treatment. The trial is crucial as current CKD management often fails to address the underlying causes of the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with chronic kidney disease stages 3 to 5.
Not a fit: Patients with severe comorbid conditions or those with hypersensitivity to study components may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option that may slow the progression of chronic kidney disease and improve patients' quality of life.
How similar studies have performed: While the approach of using adipose-derived stem cells is emerging, similar studies have shown promise, but this specific application for CKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient is eligible for the study if all of the followings apply: 1. Aged 18-80 years (inclusive) 2. With chronic kidney disease (CKD)stage 3 to 5 (eGFR 60 to 0 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate 3. Having provided informed written consent. Exclusion Criteria: Any patient meeting any of the exclusion criteria will be excluded from study participation. 1. Known hypersensitivity to any component used in the study. 2. With inadequate hematologic function with: absolute neutrophil count (ANC) \<1,500/μL OR platelets \< 100,000/μL OR Hemoglobin \< 8 g/dL 3. With impaired hepatic function with: serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AKP), prothrombin time above and normal reference and serum albumin below normal reference range. 4. With hemoglobin A1c (HbA1c) \> 8.0% 5. With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely effect the safety of the patient 6. Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period 7. With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis 8. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation 9. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial 10. Known or suspected abuse of alcohol or narcotics 11. With known history of cancer within past 5 years 12. With any autoimmune disease 13. With congenital kidney disease 14. With precancerous condition or with raised tumour markers like Alpha feto protein, Carcino embryonic antigen (CEA), C.A 19.9, C.A 125, Serum PSA above normal reference range. 15. Parcipants having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) less than 1 x 10\^6 will be excluded from the study.
Where this trial is running
Dhaka
- Bangladesh Laser And Cell Surgery Institute And Hospital — Dhaka, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Prof. Dr. Md. Firoj Khan, MBBS,FRCP,MD — Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.
- Study coordinator: Dr. Jahangir Md. Sarwar, MBBS;FCPS
- Email: jmsarwar2002@gmail.com
- Phone: +8801714044154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.