A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease

This is a phase 2b randomized, double-blind, Placebo-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem vs. Placebo treatment in patients with mild Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem every 4 weeks from Week 0 to Week 36. On the other hand, patients who are randomized into the placebo control group will receive Placebo every 4 weeks from Week 0 to Week 36. After the final administration, patients will be scheduled for two follow-up visits, at Weeks 44 and 52, to assess efficacy and safety endpoints.

Start Date01 Feb 2023

Sponsor / Collaborator-

NCT03979898

/ CompletedEarly Phase 1

Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Cerebral Palsy (CP)

Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

Start Date15 Jun 2017

Sponsor / Collaborator

R Bio Co., Ltd.

[+1]

NCT03117738

/ CompletedPhase 1/2

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.

Start Date09 May 2017

Sponsor / Collaborator

Nature Cell Co. Ltd.

100 Clinical Results associated with Mesenchymal stem cell therapy (K-STEMCELL)

100 Translational Medicine associated with Mesenchymal stem cell therapy (K-STEMCELL)

100 Patents (Medical) associated with Mesenchymal stem cell therapy (K-STEMCELL)

Literatures (Medical) associated with Mesenchymal stem cell therapy (K-STEMCELL)

29 Jul 2023·Biomedicines

Effects of Mesenchymal Stem Cell Injection into Healed Myocardial Infarction Scar Border Zone on the Risk of Ventricular Tachycardia.

Article

Author: Park, Eun-Hye ; Seong, EunHwa ; Kim, Jin-Moo ; Choi, Young ; Lee, Eunmi ; Chang, Kiyuk

The scar border zone is a main source of reentry responsible for ischemic ventricular tachycardia (VT). We evaluated the effects of mesenchymal stem cell (MSC) injection into the scar border zone on arrhythmic risks in a post-myocardial infarction (MI) animal model. Rabbit MI models were generated by left descending coronary artery ligation. Surviving rabbits after 4 weeks underwent left thoracotomy and autologous MSCs or phosphate-buffered saline (PBS) was administered to scar border zones in two rabbits in each group. Another rabbit without MI underwent a sham procedure (control). An implantable loop recorder (ILR) was implanted in the left chest wall in all animals. Four weeks after cell injections, ventricular fibrillation was induced in 1/2 rabbit in the PBS group by electrophysiologic study, and no ventricular arrhythmia was induced in the MSC group or control. Spontaneous VT was not detected during ILR analysis in any animal for 4 weeks. Histologic examination showed restoration of connexin 43 (Cx43) expression in the MSC group, which was higher than in the PBS group and comparable to the control. In conclusion, MSC injections into the MI scar border zone did not increase the risk of VT and were associated with favorable Cx43 expression and arrangement.

01 Mar 2023·Transplantation Proceedings

Autologous Synovial Mesenchymal Stem Cell Transplantation Suppresses Inflammation Caused by Synovial Harvesting and Promotes Healing in a Micro Minipig Repaired Meniscus Model

Article

Author: Nakamura, Kentaro ; Kubota, Rei ; Furuoka, Hideto ; Ozeki, Nobutake ; Kushida, Yoshihisa ; Ohya, Shoji ; Mizuno, Mitsuru ; Yanada, Shinobu ; Sekiya, Ichiro ; Katano, Hisako ; Koga, Hideyuki ; Okada, Takuya ; Endo, Kentaro

PURPOSEAllogeneic synovial mesenchymal stem cells (MSCs) effectively promote meniscus healing in micro minipigs. We investigated the effect of autologous synovial MSC transplantation on meniscus healing in a micro minipig model of meniscus repair showing synovitis after synovial harvesting.MATERIALS AND METHODSSynovium was harvested from the left knee of the micro minipigs after arthrotomy and used to prepare synovial MSCs. The left medial meniscus in the avascular region was injured, repaired, and transplanted with synovial MSCs. First, synovitis was compared after 6 weeks in knees with and without synovial harvesting. Second, the repaired meniscus was compared for the autologous MSC group and the control group (in which synovium was harvested but MSCs were not transplanted) 4 weeks after transplantation.RESULTSSynovitis was more severe in knees subjected to synovium harvesting than in knees not subjected to harvesting. Menisci treated with autologous MSCs showed no red granulation at the tear of the meniscus, but menisci not treated with MSCS showed red granulation. Macroscopic scores, inflammatory cell infiltration scores, and matrix scores assessed by toluidine blue staining were all significantly better in the autologous MSC group than in the control group without MSCs (n = 6).CONCLUSIONAutologous synovial MSC transplantation suppressed the inflammation caused by synovial harvesting in micro minipigs and promoted healing of the repaired meniscus.

01 Nov 2021·The Lancet NeurologyQ1 · MEDICINE

Safety, tolerability, and activity of mesenchymal stem cells versus placebo in multiple sclerosis (MESEMS): a phase 2, randomised, double-blind crossover trial

Q1 · MEDICINE

Article

Author: Introna, Martino ; Gimona, Mario ; Nicholas, Richard ; Mallik, Shahrukh ; Strunk, Dirk ; Cellerino, Maria ; Thalamas, Claire ; Courtman, David ; Marrie, Ruth Ann ; Uccelli, Antonio ; Nabavi, Seyed Massood ; Freedman, Mark S. ; Freedman, Mark S ; Le Blanc, Katarina ; Ramo Tello, Cristina ; Miller, David ; Sensebe, Luc ; Marriot, James ; Szwajcer, David ; Radue, Ernst ; Orengo, Giovanni ; Dazzi, Francesco ; Allan, David ; Wuerfel, Jens Thomas ; Sellner, Johann ; Inglese, Matilde ; Ali, Rehiana ; Capelli, Chiara ; Muraro, Paolo A. ; Blinkenberg, Morten ; Battaglia, Mario Alberto ; Laroni, Alice ; Berry, Isabelle ; Bonetti, Bruno ; Clanet, Michel ; Furlan, Roberto ; Fernandez, Oscar ; Iacobaeus, Ellen ; Soelberg Sorensen, Per ; Karimi, Shahedeh ; Marriott, James ; Izquierdo, Guillermo ; Sorensen, Per Soelberg ; Oliveri, Roberto S ; Cencioni, Maria Teresa ; Marley, Stephen ; Schiavetti, Irene ; Arab, Leila ; Comi, Giancarlo ; Aghdami, Naser ; Battaglia, Mario ; Sormani, Maria Pia ; Gualandi, Francesca ; Fischer-Nielsen, Anne ; Guan, Qingdong ; Fernandez, Victoria ; Martino, Gianvito ; Muraro, Paolo ; Loaiza, Sandra ; Pardini, Matteo ; Castellan, Lucio ; Rush, Carolina ; Palanicawande, Renuka ; Radue, Ernst W ; Brundin, Lou ; Agüera-Morales, Eduardo

BACKGROUNDMesenchymal stem cells (MSCs), also known as mesenchymal stromal cells, have been proposed as a promising therapeutic option for people with multiple sclerosis on the basis of their immunomodulatory and neuroprotective properties. The MEsenchymal StEm cells for Multiple Sclerosis (MESEMS) study was devised to evaluate the safety, tolerability, and activity of autologous MSCs derived from bone marrow and infused intravenously in patients with active multiple sclerosis.METHODSMESEMS is a randomised phase 2 trial done at 15 sites in nine countries. Patients (aged 18-50 years) with active relapsing-remitting or progressive multiple sclerosis were included if they had a disease duration of 2-15 years since onset of multiple sclerosis and an Expanded Disability Status Scale score of 2·5-6·5. Patients were randomly assigned (1:1), according to a crossover design, to receive a single intravenous dose of autologous bone marrow-derived MSCs followed by placebo at week 24, or to receive placebo followed by autologous MSCs at week 24, with a follow-up visit at week 48. Primary objectives were to test safety and activity of MSC treatment. The primary safety endpoint was to assess the number and severity of adverse events within each treatment arm. The primary efficacy endpoint was the number of gadolinium-enhancing lesions (GELs) counted over week 4, 12, and 24 compared between treatment groups. The primary efficacy endpoint was assessed in the full analyis set, after all participants completed the week 24 visit. Efficacy endpoints were evaluated using a predefined statistical testing procedure. Safety was monitored throughout the study by recording vital signs and adverse events at each visit.FINDINGSFrom July 16, 2012, until July 31, 2019, 144 patients were randomly assigned to first receive early intravenous infusion of autologous bone marrow-derived MSCs (n=69) or placebo (n=75). MSC treatment did not meet the primary endpoint of efficacy on the total number of GELs accumulated from baseline to week 24 (rate ratio [RR] 0·94, 95% CI 0·58-1·50; p=0·78). 213 adverse events were recorded, similarly distributed between groups (93 cases recorded in 35 [51%] of 69 patients treated first with MSCs vs 120 cases in 42 [56%] of 75 patients infused first with placebo). The most frequent adverse events reported were infection and infestations, with a total of 54 (25%) of 213 adverse events (18 [19%] of 93 in the early-MSC group and 36 [30%] of 120 in the delayed-MSC group). Nine serious adverse events were reported in seven patients treated with placebo versus none in the MSC group. All serious adverse events were considered to be unrelated to the treatment infusion. No deaths were reported during the study.INTERPRETATIONBone marrow-derived MSC treatment was safe and well tolerated but did not show an effect on GELs, an MRI surrogate marker of acute inflammation, in patients with active forms of multiple sclerosis, at week 24. Thus, this study does not support the use of bone marrow-derived MSCs to treat active multiple sclerosis. Further studies should address the effect of MSCs on parameters related to tissue repair.FUNDINGFondazione Italiana Sclerosi Multipla (FISM), the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), and the Multiple Sclerosis International Federation (MSIF) for centralised activities. Individual trials participating in the MESEMS network are funded by the following agencies: FISM and Compagnia di San Paolo (Italy); The Danish Multiple Sclerosis Society, The Toyota Foundation, and Danish Blood Donors' Research Foundation (Denmark); the Spanish Health Research Institute Carlos 3 and the Andalusian Public Foundation Progreso y Salud (Spain); the Royan Institute for Stem Cell Biology and Technology (Iran); the Spinal Cord Injury and Tissue Regeneration Centre Salzburg, Paracelsus Medical University, and Salzburg (Austria); the Fondation pour l'aide à la recherche sur la sclérose en plaques (ARSEP), French Muscular Dystrophy Association (AFM)-Telethon (France); the UK Multiple Sclerosis Society and the UK Stem Cell Foundation (UK); and the Multiple Sclerosis Society of Canada and The Multiple Sclerosis Scientific Research Foundation and Research Manitoba (Canada).

100 Deals associated with Mesenchymal stem cell therapy (K-STEMCELL)

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis	Preclinical	South Korea	BPH Global Ltd.	27 May 2019
Alzheimer Disease	Preclinical	United States	Nature Cell Co. Ltd.	09 May 2017
Spinal Cord Injuries	Preclinical	South Korea	BPH Global Ltd.	27 Jan 2013
Femur Head Necrosis	Preclinical	South Korea	BPH Global Ltd.	12 May 2012
Thromboangiitis Obliterans	Preclinical	South Korea	BPH Global Ltd.	01 Dec 2007
Cerebral Palsy	Preclinical	South Korea	-	-
Facial Hemiatrophy	Preclinical	South Korea	BPH Global Ltd.	-
Facial Hemiatrophy	Preclinical	South Korea	Asan Medical Center	-
Liver Diseases	Preclinical	Asia	BPH Global Ltd.	-
Peripheral Vascular Diseases	Preclinical	South Korea	BPH Global Ltd.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03117738 (CTgov)	Phase 1/2	Alzheimer Disease	21	AstroStem (AstroStem)	(sqqanehqpx) = vilbfplqwz dmbdaetbee (itcxkoldmj, omxyxyjxyx - vddfdfegbb) View more	-	09 Jul 2021
				Placebo-Control (Placebo-Control)	(sqqanehqpx) = vxlusuvnpy dmbdaetbee (itcxkoldmj, rkfgbntyfz - ngsioubsdp) View more

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