Clinical trial of autologous adipose tissue-derived regenerative (stem) cells therapy for exploration of its safety and efficacy

BACKGROUND Liver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis ultimately leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Therefore, novel therapies to inhibit disease progression of cirrhosis are needed. OBJECTIVE The objective of this investigator-initiated clinical trial is to assess the safety and efficacy of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via the hepatic artery in patients with liver cirrhosis. METHODS Through consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative (stem) cells, which are extracted using an adipose tissue dissociation device. The primary endpoints of the trial are the serum albumin concentration, prothrombin activity, harmful events, and device malfunction. RESULTS Enrollment and registration were initiated in November 2017, and the follow-up period ended in November 2019. Data analysis and the clinical study report will be completed by the end of March 2020. CONCLUSIONS Completion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative (stem) cells using an adipose tissue dissociation device. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17904

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Regenerative Therapy for Liver Cirrhosis Based on Intrahepatic Arterial Infusion of Autologous Subcutaneous Adipose Tissue-Derived Regenerative (Stem) Cells: Protocol for a Confirmatory Multicenter Uncontrolled Clinical Trial

JMIR Research Protocols ◽

10.2196/17904 ◽

2020 ◽

Vol 9 (3) ◽

pp. e17904 ◽

Cited By ~ 1

Author(s):

Yoshio Sakai ◽

Shinya Fukunishi ◽

Masayuki Takamura ◽

Oto Inoue ◽

Shinichiro Takashima ◽

...

Keyword(s):

Clinical Trial ◽

Stem Cells ◽

Adipose Tissue ◽

Liver Cirrhosis ◽

Data Analysis ◽

Albumin Concentration ◽

Safety And Efficacy ◽

Tissue Dissociation ◽

Primary Endpoints ◽

Clinical Trials Registry

Background Liver cirrhosis results from chronic hepatitis, and is characterized by advanced fibrosis due to long-term hepatic inflammation. Cirrhosis ultimately leads to manifestations of jaundice, ascites, and encephalopathy, and increases the risk of hepatocellular carcinoma. Once cirrhosis is established, resulting in hepatic failure, no effective treatment is available. Therefore, novel therapies to inhibit disease progression of cirrhosis are needed. Objective The objective of this investigator-initiated clinical trial is to assess the safety and efficacy of autologous adipose tissue-derived regenerative (stem) cell therapy delivered to the liver via the hepatic artery in patients with liver cirrhosis. Methods Through consultation with the Japan Pharmaceuticals and Medical Devices Agency, we designed a clinical trial to assess a therapy for liver cirrhosis based on autologous adipose tissue-derived regenerative (stem) cells, which are extracted using an adipose tissue dissociation device. The primary endpoints of the trial are the serum albumin concentration, prothrombin activity, harmful events, and device malfunction. Results Enrollment and registration were initiated in November 2017, and the follow-up period ended in November 2019. Data analysis and the clinical study report will be completed by the end of March 2020. Conclusions Completion of this clinical trial, including data analysis, will provide data on the safety and efficacy of this novel liver repair therapy based on autologous adipose tissue-derived regenerative (stem) cells using an adipose tissue dissociation device. Trial Registration UMIN Clinical Trials Registry UMIN000022601; https://tinyurl.com/w9uqw3q International Registered Report Identifier (IRRID) DERR1-10.2196/17904

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Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn’s disease: a phase II clinical trial for safety and efficacy

Techniques in Coloproctology ◽

10.1007/s10151-017-1630-z ◽

2017 ◽

Vol 21 (5) ◽

pp. 345-353 ◽

Cited By ~ 14

Author(s):

S. Choi ◽

S.-B. Ryoo ◽

K. J. Park ◽

D.-S. Kim ◽

K.-H. Song ◽

...

Keyword(s):

Clinical Trial ◽

Stem Cells ◽

Adipose Tissue ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Phase Ii ◽

Phase Ii Clinical Trial ◽

Safety And Efficacy ◽

Perianal Fistulas

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Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial

Journal of Dental Research ◽

10.1177/0022034520913242 ◽

2020 ◽

Vol 99 (5) ◽

pp. 523-529 ◽

Cited By ~ 4

Author(s):

C. Brizuela ◽

G. Meza ◽

D. Urrejola ◽

M.A. Quezada ◽

G. Concha ◽

...

Keyword(s):

Clinical Trial ◽

Stem Cells ◽

Mesenchymal Stem Cells ◽

Phase I ◽

Umbilical Cord ◽

Root Canal ◽

Categorical Variables ◽

Safety And Efficacy ◽

Randomized Controlled

A randomized controlled phase I/II clinical trial was designed to evaluate the safety and efficacy of encapsulated human umbilical cord mesenchymal stem cells in a plasma-derived biomaterial for regenerative endodontic procedures (REPs) in mature permanent teeth with apical lesions. The trial included 36 patients with mature incisors, canines, or mandibular premolars showing pulp necrosis and apical periodontitis. Patients were randomly and equally allocated between experimental (REP) or conventional root canal treatment (ENDO) groups. On the first visit, cavity access and mechanical preparation of the root canal were performed. Calcium hydroxide medication was used, and the cavity was sealed. Three weeks later, patients were treated following their assigned protocol of ENDO or REP. Clinical follow-up examinations were performed at 6 and 12 mo. Categorical variables were evaluated by Fisher’s exact test. Quantitative variables were compared using the Mann-Whitney test. The evolution over time of the percentage of perfusion units and the dimensions of lesion and cortical compromise were explored. After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups. Interestingly, in the REP group, the perfusion unit percentage measured by laser Doppler flowmetry revealed an increase from 60.6% to 78.1% between baseline and 12-mo follow-up. Sensitivity tests revealed an increase of the positive pulp response in the REP group at 12-mo follow-up (from 6% to 56% on the cold test, from 0% to 28% on the hot test, and from 17% to 50% on the electrical test). We present the first clinical safety and efficacy evidence of the endodontic use of allogenic umbilical cord mesenchymal stem cells encapsulated in a plasma-derived biomaterial. The innovative approach, based on biological principles that promote dentin-pulp regeneration, presents a promising alternative for the treatment of periapical pathology (ClinicalTrials.gov NCT03102879).

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CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue–Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury

Mayo Clinic Proceedings ◽

10.1016/j.mayocp.2019.10.008 ◽

2020 ◽

Vol 95 (2) ◽

pp. 406-414 ◽

Cited By ~ 11

Author(s):

Mohamad Bydon ◽

Allan B. Dietz ◽

Sandy Goncalves ◽

F M Moinuddin ◽

Mohammed Ali Alvi ◽

...

Keyword(s):

Clinical Trial ◽

Spinal Cord ◽

Stem Cells ◽

Spinal Cord Injury ◽

Mesenchymal Stem Cells ◽

Adipose Tissue ◽

Phase 1 ◽

Traumatic Spinal Cord Injury ◽

Phase 1 Trial ◽

Cord Injury

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The Effect of Autologous Adipose Tissue–Derived Mesenchymal Stem Cells’ Therapy in the Treatment of Chronic Posttraumatic Spinal Cord Injury in a Domestic Ferret Patient

Cell Transplantation ◽

10.1177/0963689720928982 ◽

2020 ◽

Vol 29 ◽

pp. 096368972092898

Author(s):

Agata Przekora ◽

Lukasz Juszkiewicz

Keyword(s):

Spinal Cord ◽

Stem Cells ◽

Spinal Cord Injury ◽

Mesenchymal Stem Cells ◽

Adipose Tissue ◽

Clinical Intervention ◽

Experimental Treatment ◽

Cell Based Therapy ◽

Cord Injury ◽

Stem Cells Therapy

Spinal cord injury (SCI) is considered as one of the most problematic neurological conditions requiring specialized clinical intervention. Taking into account that SCI is characterized by extensive loss of nerve cells, stem cell–based therapy seems to be a reasonable modern strategy to the treatment of SCI. The presented case report describes for the first time experimental treatment with the use of autologous adipose tissue–derived mesenchymal stem cells (ADSCs) of the chronic posttraumatic SCI in a domestic ferret patient with paresis of back legs. It should be noted that most reports in the available literature concern ADSC-based therapies for acute or subacute SCI treatment in other species. Application of ADSC-based therapy did not cause any adverse reactions and resulted in significant improvement of neurological and motor functions. Based on these outcomes, it may be concluded that this form of therapy is promising and may be potentially translated into clinical veterinary practice.

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