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

NCT03939741 | Unknown Phase 1 DMC

• 1 other identifier: BangladeshLCS001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To assess the safety of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD).
2. 2.To assess the efficacy of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD).

Conditions

Chronic Kidney Diseases

Keywords

Chronic kidney disease; Stromal vascular fraction; Adipose derived stem cell

Outcome Measures

Primary Outcomes (4)

• Incidence of minor adverse events (MAEs) , serious adverse events (SAEs) which may be immediate, early or late - for Phase I

  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)

  Week 48

• Change from baseline to 24 week visit in glomerular filtration rate (GFR) and split renal function in all patients - for Phase II

  GFR with split renal function will be evaluated using DTPA Renogram.

  Weeks 0, 24

• 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

  eGFR will be calculated by Serum Creatinine level using MRDR formula during all visits.

  Weeks 0, 2, 4, 12, 24

• Change from baseline to 24 week visit in need for dialysis in patients with CKD 5 - for phase II

  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

  Weeks 0, 2, 4, 12, 24

Secondary Outcomes (19)

• Change from baseline to all post-treatment visits in body weight

  Weeks 0, 2, 4, 12, 24, 36, 48

• Change from baseline to all post-treatment visits in Blood-pressure

  Weeks 0, 2, 4, 12, 24, 36, 48

• Change from baseline to all post-treatment visits in S.creatinine

  Weeks 0, 2, 4, 12, 24, 36, 48

• Change from baseline to all post-treatment visits in blood urea.

  Weeks 0, 2, 4, 12, 24, 36, 48

• Change from baseline to all post-treatment visits in Hemoglobin level

  Weeks 0, 2, 4, 12, 24, 36, 48

Study Arms (1)

Group A

EXPERIMENTAL

Participants having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) more than 1 x 10\^6. Genetic: SVF containing Autologous Non Expanded ADSC.

Biological: SVF Containg Autologous Non Expanded ADSC

Interventions

SVF Containg Autologous Non Expanded ADSC BIOLOGICAL

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.

Group A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient is eligible for the study if all of the followings apply:
• Aged 18-80 years (inclusive)
• With chronic kidney disease (CKD)stage 3 to 5 (eGFR 60 to 0 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
• Having provided informed written consent.

You may not qualify if:

• Known hypersensitivity to any component used in the study.
• With inadequate hematologic function with: absolute neutrophil count (ANC) \<1,500/μL OR platelets \< 100,000/μL OR Hemoglobin \< 8 g/dL
• 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.
• With hemoglobin A1c (HbA1c) \> 8.0%
• 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
• Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
• With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
• Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
• With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
• Known or suspected abuse of alcohol or narcotics
• With known history of cancer within past 5 years
• With any autoimmune disease
• With congenital kidney disease
• 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.
• 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.

Sponsors & Collaborators

• Bangladesh Laser & Cell Surgery Institute & Hospital: lead

Study Sites (1)

Bangladesh Laser And Cell Surgery Institute And Hospital

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (38)

• Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.

  PMID: 23727169 BACKGROUND

• Gilbertson DT, Liu J, Xue JL, Louis TA, Solid CA, Ebben JP, Collins AJ. Projecting the number of patients with end-stage renal disease in the United States to the year 2015. J Am Soc Nephrol. 2005 Dec;16(12):3736-41. doi: 10.1681/ASN.2005010112. Epub 2005 Nov 2.

  PMID: 16267160 BACKGROUND

• 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.

  BACKGROUND

• Wyld M, Morton RL, Hayen A, Howard K, Webster AC. A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease treatments. PLoS Med. 2012;9(9):e1001307. doi: 10.1371/journal.pmed.1001307. Epub 2012 Sep 11.

  PMID: 22984353 BACKGROUND

• Collins AJ, Foley RN, Chavers B, Gilbertson D, Herzog C, Johansen K, Kasiske B, Kutner N, Liu J, St Peter W, Guo H, Gustafson S, Heubner B, Lamb K, Li S, Li S, Peng Y, Qiu Y, Roberts T, Skeans M, Snyder J, Solid C, Thompson B, Wang C, Weinhandl E, Zaun D, Arko C, Chen SC, Daniels F, Ebben J, Frazier E, Hanzlik C, Johnson R, Sheets D, Wang X, Forrest B, Constantini E, Everson S, Eggers P, Agodoa L. 'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States. Am J Kidney Dis. 2012 Jan;59(1 Suppl 1):A7, e1-420. doi: 10.1053/j.ajkd.2011.11.015. No abstract available.

  PMID: 22177944 BACKGROUND

• Perico N, Remuzzi G. Chronic kidney disease: a research and public health priority. Nephrol Dial Transplant. 2012 Oct;27 Suppl 3:iii19-26. doi: 10.1093/ndt/gfs284. Epub 2012 Jul 3. No abstract available.

  PMID: 22764188 BACKGROUND

• Rivera JA, O'Hare AM, Harper GM. Update on the management of chronic kidney disease. Am Fam Physician. 2012 Oct 15;86(8):749-54.

  PMID: 23062158 BACKGROUND

• Benigni A, Morigi M, Remuzzi G. Kidney regeneration. Lancet. 2010 Apr 10;375(9722):1310-7. doi: 10.1016/S0140-6736(10)60237-1.

  PMID: 20382327 BACKGROUND

• Riordan NH, Ichim TE, Min WP, Wang H, Solano F, Lara F, Alfaro M, Rodriguez JP, Harman RJ, Patel AN, Murphy MP, Lee RR, Minev B. Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis. J Transl Med. 2009 Apr 24;7:29. doi: 10.1186/1479-5876-7-29.

  PMID: 19393041 BACKGROUND

• Schipper HS, Prakken B, Kalkhoven E, Boes M. Adipose tissue-resident immune cells: key players in immunometabolism. Trends Endocrinol Metab. 2012 Aug;23(8):407-15. doi: 10.1016/j.tem.2012.05.011. Epub 2012 Jul 12.

  PMID: 22795937 BACKGROUND

• Reinders ME, Fibbe WE, Rabelink TJ. Multipotent mesenchymal stromal cell therapy in renal disease and kidney transplantation. Nephrol Dial Transplant. 2010 Jan;25(1):17-24. doi: 10.1093/ndt/gfp552. Epub 2009 Oct 26.

  PMID: 19861311 BACKGROUND

• Peired AJ, Sisti A, Romagnani P. Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. Stem Cells Int. 2016;2016:4798639. doi: 10.1155/2016/4798639. Epub 2016 Sep 19.

  PMID: 27721835 BACKGROUND

• Kokai LE, Rubin JP, Marra KG. The potential of adipose-derived adult stem cells as a source of neuronal progenitor cells. Plast Reconstr Surg. 2005 Oct;116(5):1453-60. doi: 10.1097/01.prs.0000182570.62814.e3.

  PMID: 16217495 BACKGROUND

• Lin CS, Xin ZC, Deng CH, Ning H, Lin G, Lue TF. Defining adipose tissue-derived stem cells in tissue and in culture. Histol Histopathol. 2010 Jun;25(6):807-15. doi: 10.14670/HH-25.807.

  PMID: 20376787 BACKGROUND

• Lin F. Adipose tissue-derived mesenchymal stem cells: a fat chance of curing kidney disease? Kidney Int. 2012 Oct;82(7):731-3. doi: 10.1038/ki.2012.158.

  PMID: 22975993 BACKGROUND

• 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

  BACKGROUND

• Stashower M, Smith K, Williams J, Skelton H. Stromal progenitor cells present within liposuction and reduction abdominoplasty fat for autologous transfer to aged skin. Dermatol Surg. 1999 Dec;25(12):945-9. doi: 10.1046/j.1524-4725.1999.99098.x.

  PMID: 10594628 BACKGROUND

• Halvorsen YC, Wilkison WO, Gimble JM. Adipose-derived stromal cells--their utility and potential in bone formation. Int J Obes Relat Metab Disord. 2000 Nov;24 Suppl 4:S41-4. doi: 10.1038/sj.ijo.0801503.

  PMID: 11126240 BACKGROUND

• Moseley TA, Zhu M, Hedrick MH. Adipose-derived stem and progenitor cells as fillers in plastic and reconstructive surgery. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):121S-128S. doi: 10.1097/01.prs.0000234609.74811.2e.

  PMID: 16936551 BACKGROUND

• Kidney disease: how could stem cells help?. http://www.eurostemcell.org /factsheet/kidney-disease-how-could-stem-cells-help

  BACKGROUND

• Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, Claas FH, van Miert PP, Roelen DL, van Kooten C, Fibbe WE, Rabelink TJ. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after renal transplantation: results of a phase I study. Stem Cells Transl Med. 2013 Feb;2(2):107-11. doi: 10.5966/sctm.2012-0114. Epub 2013 Jan 24.

  PMID: 23349326 BACKGROUND

• Eirin A, Lerman LO. Mesenchymal stem cell treatment for chronic renal failure. Stem Cell Res Ther. 2014 Jul 4;5(4):83. doi: 10.1186/scrt472.

  PMID: 25158205 BACKGROUND

• Rehman J, Traktuev D, Li J, Merfeld-Clauss S, Temm-Grove CJ, Bovenkerk JE, Pell CL, Johnstone BH, Considine RV, March KL. Secretion of angiogenic and antiapoptotic factors by human adipose stromal cells. Circulation. 2004 Mar 16;109(10):1292-8. doi: 10.1161/01.CIR.0000121425.42966.F1. Epub 2004 Mar 1.

  PMID: 14993122 BACKGROUND

• Meliga E, Strem BM, Duckers HJ, Serruys PW. Adipose-derived cells. Cell Transplant. 2007;16(9):963-70. doi: 10.3727/096368907783338190.

  PMID: 18293895 BACKGROUND

• Thum T, Bauersachs J, Poole-Wilson PA, Volk HD, Anker SD. The dying stem cell hypothesis: immune modulation as a novel mechanism for progenitor cell therapy in cardiac muscle. J Am Coll Cardiol. 2005 Nov 15;46(10):1799-802. doi: 10.1016/j.jacc.2005.07.053. Epub 2005 Oct 17.

  PMID: 16286162 BACKGROUND

• Banas A, Teratani T, Yamamoto Y, Tokuhara M, Takeshita F, Osaki M, Kawamata M, Kato T, Okochi H, Ochiya T. IFATS collection: in vivo therapeutic potential of human adipose tissue mesenchymal stem cells after transplantation into mice with liver injury. Stem Cells. 2008 Oct;26(10):2705-12. doi: 10.1634/stemcells.2008-0034. Epub 2008 Jun 5.

  PMID: 18535155 BACKGROUND

• Villanueva S, Carreno JE, Salazar L, Vergara C, Strodthoff R, Fajre F, Cespedes C, Saez PJ, Irarrazabal C, Bartolucci J, Figueroa F, Vio CP. Human mesenchymal stem cells derived from adipose tissue reduce functional and tissue damage in a rat model of chronic renal failure. Clin Sci (Lond). 2013 Aug;125(4):199-210. doi: 10.1042/CS20120644.

  PMID: 23480877 BACKGROUND

• Quimby JM, Webb TL, Habenicht LM, Dow SW. Safety and efficacy of intravenous infusion of allogeneic cryopreserved mesenchymal stem cells for treatment of chronic kidney disease in cats: results of three sequential pilot studies. Stem Cell Res Ther. 2013 Apr 30;4(2):48. doi: 10.1186/scrt198.

  PMID: 23632128 BACKGROUND

• Zhang L, Li K, Liu X, Li D, Luo C, Fu B, Cui S, Zhu F, Zhao RC, Chen X. Repeated systemic administration of human adipose-derived stem cells attenuates overt diabetic nephropathy in rats. Stem Cells Dev. 2013 Dec 1;22(23):3074-86. doi: 10.1089/scd.2013.0142. Epub 2013 Aug 21.

  PMID: 23844841 BACKGROUND

• Papazova DA, Oosterhuis NR, Gremmels H, van Koppen A, Joles JA, Verhaar MC. Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis. Dis Model Mech. 2015 Mar;8(3):281-93. doi: 10.1242/dmm.017699. Epub 2015 Jan 29.

  PMID: 25633980 BACKGROUND

• Malaga-Dieguez L, Bouhassira D, Gipson D, Trachtman H. Novel therapies for FSGS: preclinical and clinical studies. Adv Chronic Kidney Dis. 2015 Mar;22(2):e1-6. doi: 10.1053/j.ackd.2014.10.001.

  PMID: 25704355 BACKGROUND

• You D, Jang MJ, Lee J, Suh N, Jeong IG, Sohn DW, Kim SW, Ahn TY, Kim CS. Comparative analysis of periprostatic implantation and intracavernosal injection of human adipose tissue-derived stem cells for erectile function recovery in a rat model of cavernous nerve injury. Prostate. 2013 Feb 15;73(3):278-86. doi: 10.1002/pros.22567. Epub 2012 Jul 20.

  PMID: 22821215 BACKGROUND

• Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.

  PMID: 18489988 BACKGROUND

• Fischer UM, Harting MT, Jimenez F, Monzon-Posadas WO, Xue H, Savitz SI, Laine GA, Cox CS Jr. Pulmonary passage is a major obstacle for intravenous stem cell delivery: the pulmonary first-pass effect. Stem Cells Dev. 2009 Jun;18(5):683-92. doi: 10.1089/scd.2008.0253.

  PMID: 19099374 BACKGROUND

• Zonta S, De Martino M, Bedino G, Piotti G, Rampino T, Gregorini M, Frassoni F, Dal Canton A, Dionigi P, Alessiani M. Which is the most suitable and effective route of administration for mesenchymal stem cell-based immunomodulation therapy in experimental kidney transplantation: endovenous or arterial? Transplant Proc. 2010 May;42(4):1336-40. doi: 10.1016/j.transproceed.2010.03.081.

  PMID: 20534295 BACKGROUND

• Bi B, Schmitt R, Israilova M, Nishio H, Cantley LG. Stromal cells protect against acute tubular injury via an endocrine effect. J Am Soc Nephrol. 2007 Sep;18(9):2486-96. doi: 10.1681/ASN.2007020140. Epub 2007 Jul 26.

  PMID: 17656474 BACKGROUND

• Lee SR, Lee SH, Moon JY, Park JY, Lee D, Lim SJ, Jeong KH, Park JK, Lee TW, Ihm CG. Repeated administration of bone marrow-derived mesenchymal stem cells improved the protective effects on a remnant kidney model. Ren Fail. 2010;32(7):840-8. doi: 10.3109/0886022X.2010.494803.

  PMID: 20662698 BACKGROUND

• Semedo P, Correa-Costa M, Antonio Cenedeze M, Maria Avancini Costa Malheiros D, Antonia dos Reis M, Shimizu MH, Seguro AC, Pacheco-Silva A, Saraiva Camara NO. Mesenchymal stem cells attenuate renal fibrosis through immune modulation and remodeling properties in a rat remnant kidney model. Stem Cells. 2009 Dec;27(12):3063-73. doi: 10.1002/stem.214.

  PMID: 19750536 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. Md. Firoj Khan, MBBS,FRCP,MD

  Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.

  PRINCIPAL INVESTIGATOR

• Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, PhD

  Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.

  STUDY CHAIR

• Dr. Jahangir Md. Sarwar, MBBS, FCPS

  Bangladesh Laser and Cell Surgery Institute and Hospital, Dhaka, Bangladesh.

  STUDY DIRECTOR

Central Study Contacts

Dr. Jahangir Md. Sarwar, MBBS;FCPS

CONTACT

+8801714044154; jmsarwar2002@gmail.com

Dr. Mohammed Yakub Ali MBBS, MPhil, MSc, PhD

CONTACT

+8801745490789; myalibd@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be placed in a single group. Those having a harvested total "Adipose Derived Stem Cell (ADSC)" count (in 5 ml SVF solution) above 1 x 10\^6 will be included in the study and they 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.

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: April 1, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)