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Trial record 29 of 523 for:    stem cell kidney

SVF (Adipose Tissue Derived MSC) Based Therapy for CKD. (StemCell&CKD)

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ClinicalTrials.gov Identifier: NCT03939741
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bangladesh Laser & Cell Surgery Institute & Hospital

Brief Summary:
  1. To assess the safety of stromal vascular fraction (Autologous Non Expanded ADSC) injection to patients with Chronic Kidney Disease.
  2. To assess the efficacy of stromal vascular fraction (Autologous Non Expanded ADSC) injection to patients with Chronic Kidney Disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Biological: SVF Containg Autologous Non Expanded ADSC Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be placed in either of the 2 groups, depending on the number of harvested total stem cell count.

Those having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) between 1 x 10^6 to 2 x 10^6 will be placed in "Group A".

Those having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) more than 2 x 10^6 will be placed in "Group B".

Both groups will be studied for Phase I/ Phase II trial by the proposed outcome measures over the stipulated time frame.

Those 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.

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Therapeutic Potential of Stromal Vascular Fraction (Autologous Adipose Derived Mesenchymal Stem Cell) Based Treatment for Chronic Kidney Disease
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Group A

Participants having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) between 1 x 10^6 to 2 x 10^6.

Genetic: SVF containing Autologous Non Expanded ADSC.

Biological: SVF Containg Autologous Non Expanded ADSC
5 ml of SVF containing Autologous Non Expanded ADSC will be injected intravenously and outcome will be observed over the period of 1(one) year.

Experimental: Group B

Participants having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) more than 2 x 10^6.

Genetic: SVF containing Autologous Non Expanded ADSC

Biological: SVF Containg Autologous Non Expanded ADSC
5 ml of SVF containing Autologous Non Expanded ADSC will be injected intravenously and outcome will be observed over the period of 1(one) year.




Primary Outcome Measures :
  1. Incidence of minor adverse events (MAEs) , serious adverse events (SAEs) which may be immediate, early or late - for Phase I [ Time Frame: Week 48 ]

    Minor adverse events (MAEs):

    1. Pain from lipo-suction > 7 days (Early)
    2. Fever > 7 days (Early)
    3. Subcutaneous hematoma / abscess formation (Early)
    4. Allergic reaction (Immediate)

    Serious adverse events (SAEs)

    1. Anaphylaxis (Immediate)
    2. Pulmonary embolism or infarction (Immediate)
    3. Outset of any neoplastic change (Late)
    4. Outset of new Cardiovascular events (Late)
    5. Outset of new Cerebrovascular or neurological events (Late)
    6. Reactivation of treated tuberculosis (Late)

  2. Change from baseline to 24 week visit in estimated glomerular filtration rate (eGFR) and split renal function in all patients - for Phase II [ Time Frame: Weeks 0, 24 ]
    eGFR with split renal function will be evaluated using DTPA Renogram.

  3. Change from baseline to 24 week visit in estimated glomerular filtration rate (eGFR) with serum creatinine level in patients with CKD 4 and below - for Phase II [ Time Frame: Weeks 0, 2, 4, 12, 24 ]
    eGFR will be calculated by Serum Creatinine level using MRDR formula during all visits.

  4. Change from baseline to 24 week visit in need for dialysis in patients with CKD 5 - for phase II [ Time Frame: Weeks 0, 2, 4, 12, 24 ]

    Need for dialysis is described as

    1. No dialysis needed - Score 0
    2. Randomly (more than 6 days interval) - Score 1
    3. At 6 (six) days interval / Once weekly - Score 2
    4. At 5 (five) days interval - Score 3
    5. At 4 (four) days interval - Score 4
    6. At 3 (three) days interval / 2 times a week - Score 5
    7. At 2 (two) days interval - Score 6
    8. At 1 (one) day interval / every alternate day./ 3 times a week - Score 7


Secondary Outcome Measures :
  1. Change from baseline to all post-treatment visits in body weight [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    Weight in Kg will be recorded for each patient during each follow up

  2. Change from baseline to all post-treatment visits in Blood-pressure [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    Blood pressure will be measured in each patient during each follow up

  3. Change from baseline to all post-treatment visits in S.creatinine [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    1. S. Creatinine level will be measured during each follow up.
    2. In case of patients having dialysis Pre and Post dialysis S. Creatinine levels will be measured at or near follow up dates.

  4. Change from baseline to all post-treatment visits in blood urea nitrogen (BUN) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    Blood Urea Nitrogen will be measured in all patients during each follow up.

  5. Change from baseline to all post-treatment visits in Hemoglobin level [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    1. Hemoglobin level will be measured in gm/dl and percentage
    2. Need for blood transfusion will be recorded
    3. Need for erythropoietin will be recorded

  6. Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    Urinary Microalbumin and creatinine will be measured in each patient during each follow up

  7. Change from baseline to all post-treatment visits in hemoglobin A1c [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    HbA1C will be measured in each patient during each follow up

  8. Change from baseline to all post-treatment visits in random blood sugar (RBS) [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    RBS will be measured in each patient during each follow up

  9. Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    Patients will be asked if he or she had experienced any episode of hypoglycemia with clinical features of altered level of consciousness, sweating, nausea or vomiting with blood glucose < 55 mg/dL or 3.0 mmol/L

  10. Change from baseline to all post-treatment visits in eGFR [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    eGFR will calculated using MDRD formula for each patient during each follow up

  11. Change from baseline to all post-treatment visits in Anti-Hypertensive medication if there is any. [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    All anti hypertensive medicines with their doses will be recorded including any changes in each patient during each follow up

  12. Change from baseline to all post-treatment visits in Hypoglycemic agent if there is any. [ Time Frame: Weeks 0, 2, 4, 12, 24, 36, 48 ]
    All hypoglycemic agents including their doses with any changes will be recorded for all diabetic patients during each follow up

  13. Change from baseline to post-treatment visits in urine total protein-creatinine ratio (UPCR) [ Time Frame: Weeks 0, 24, 48 ]
    Urinary total protein and Creatinine ratio will be done in each patient during each follow up

  14. Change from baseline to post-treatment level of serum Alpha Feto Protein [ Time Frame: Weeks 0, 24, 48 ]
    Serum Alpha Feto protein will be measured as a tumour marker for Hepato-cellular carcinoma and also Tumour of Testis and Ovary.

  15. Change from baseline to post-treatment level of serum CEA level [ Time Frame: Weeks 0, 24, 48 ]
    Serum CEA level will be measured as a tumour marker for Colo-rectal Carcinoma and also for Cancer of Stomach, pancreas, breast, lungs, thyroid and ovary.

  16. Change from baseline to post-treatment level of serum CA 19.9 level [ Time Frame: Weeks 0, 24, 48 ]
    Serum C.A 19.9 level will be measured as a tumour marker for Pancreatic Carcinoma

  17. Change from baseline to post-treatment level LDH level [ Time Frame: Weeks 0, 24, 48 ]
    Serum LDH level will be measured as tumour marker for Lymphoma

  18. Change from baseline to post-treatment level of Beta 2 Microglobulin level [ Time Frame: Weeks 0, 24,48 ]
    Serum Beta 2 Microglobulin level will be measured as a prognostic tool, as CKD patients invariably has a raised serum level.

  19. Change from baseline to post-treatment level of serum CA 125 level (in case of female patients) [ Time Frame: Weeks 0, 24, 48 ]
    Serum C.A 125 level will be measured as a tumour marker for Ovarian Cancer

  20. Change from baseline to post-treatment level of PSA level (in case of male patients) [ Time Frame: Weeks 0, 24,48 ]
    Serum PSA level will be measured as a tumour marker for Prostatic Cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939741


Contacts
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Contact: Dr. Jahangir Md. Sarwar, MBBS;FCPS +8801714044154 jmsarwar2002@gmail.com
Contact: Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, PhD +8801745490789 myalibd@hotmail.com

Locations
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Bangladesh
Bangladesh Laser And Cell Surgery Institute And Hospital Recruiting
Dhaka, Bangladesh, 1212
Contact: Dr. Jahangir Md. Sarwar, MBBS;FCPS    +8801714044154    jmsarwar2002@gmail.com   
Contact: Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, Phd    +8801745490789    myalibd@hotmail.com   
Principal Investigator: Prof. Dr. Md. Firoj Khan, MBBS,MRCP,MD         
Sub-Investigator: Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, PhD         
Sub-Investigator: Dr. Jahangir Md. Sarwar, MBBS, FCPS         
Sub-Investigator: Dr. Mohammad Shahadat Hossain, MBBS         
Sub-Investigator: Dr. Nibedita Nargis MBBS, FCPS, MD         
Sub-Investigator: Dr. Mohammad Nazmul Kayes, MBBS, DA         
Sub-Investigator: Dr. Afsana Sultana, MBBS         
Sponsors and Collaborators
Bangladesh Laser & Cell Surgery Institute & Hospital
Investigators
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Principal Investigator: Prof. Dr. Md. Firoj Khan, MBBS,FRCP,MD Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.
Study Chair: Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, PhD Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.
Study Director: Dr. Jahangir Md. Sarwar, MBBS, FCPS Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.
  Study Documents (Full-Text)

Documents provided by Bangladesh Laser & Cell Surgery Institute & Hospital:

Publications:
Prevalence of Chronic Kidney Disease (CKD) and Identification of Associated risk Factors among Rulral Population by Mass Screening. Hasan MJ , Kashem MA,, Rahman MH, Quddhush R , Rahman M, Sharmeen A, Islam N. CBMJ 2012;1(1):20-26.
Huixi Li1, 2, Guiting Lin1*, and Tom F Lue1 Potential application of adipose tissue-derived stem cells for urological disease. Bladder 2014;1(1). DOI: 10.14440/bladder.2014.23
Kidney disease: how could stem cells help?. http://www.eurostemcell.org /factsheet/kidney-disease-how-could-stem-cells-help

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Responsible Party: Bangladesh Laser & Cell Surgery Institute & Hospital
ClinicalTrials.gov Identifier: NCT03939741     History of Changes
Other Study ID Numbers: BangladeshLCS001
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bangladesh Laser & Cell Surgery Institute & Hospital:
Chronic kidney disease
Stromal vascular fraction
Adipose derived stem cell
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency