Cartistem (mesenchymal stem cell therapy for cartilage repair) / Medipost - LARVOL DELTA

CARTISTEM23-01: Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Medipost, Inc. | N=1200 ➔ 300

Enrollment change • Immunology • Osteoarthritis • Pain • Rheumatology

CARTISTEM23-01: Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Medipost, Inc.

New P3 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Korean stem cell biotechnology company MEDIPOST said it has submitted an Investigational New Drug application to the US Food and Drug Administration for its knee osteoarthritis treatment Cartistem. (Korea Biomedical Review) - "The firm expects to obtain marketing authorization in the US by around 2031 and proceed with a commercial launch shortly thereafter....MEDIPOST plans to announce the phase 3 results in the first half of 2026 and apply for marketing authorization in the second half of that year, with the goal of entering the Japanese market in 2027."

FDA approval • IND • Japan filing • P3 data • Osteoarthritis

Novel Treatment Options for Knee Cartilage Defects in 2023. (PubMed, Sports Med Arthrosc Rev) - "Cartistem is a stem-cell-based product composed of culture-expanded allogeneic human umbilical cord blood-derived mesenchymal stem cells and hyaluronic acid hydrogel, which is in its final clinical trial stages in the United States, but already has regulatory approval in Korea. IMPACT and RECLAIM studies have shown the safety and efficacy of a new one-stage procedure utilizing autologous chondrons combined with allogeneic mesenchymal stem cells (MSCs) that can provide another effective single-stage treatment option."

Journal • Review • Immunology • Rheumatology

Medipost withdraws Japanese p2 trial for stem cell therapy (Korea Biomedical Review) - "Medipost has voluntarily withdrawn its phase 2 clinical trial of Cartistem in Japan. The company said it did so to focus on a separate phase 3 monotherapy study. In a public disclosure Friday, Medipost said it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the end-of-phase 2 report of Cartistem. This comes more than four years after the PMDA approved the phase 2 clinical trial in December 2019."

Japanese regulatory • Trial withdrawal • CNS Disorders • Osteoarthritis • Pain

Medipost, 3Q sales increased by 15.8% to KRW 15.3 billion… Cord blood and Cartistem growth twins [Google translation] (Asia Economy) - "Cartistem, a stem cell treatment for osteoarthritis of the knee, also grew 27.5% compared to the same period last year based on the accumulated reliability of the product, recovering the double-digit growth rate before Corona."

Commercial • CNS Disorders • Osteoarthritis • Pain

[Featured Note] Medipost, a 'green light' for stem cell therapy entry into the US…Proven efficacy for 5 years in phase 3 clinical trials (Asia Economy) - P3 | N=103 | NCT01626677 | P3 | N=104 | NCT01041001 | Sponsor: Medipost Co Ltd. | "Medipost announced that the 48-week and 5-year long-term efficacy follow-up of patients with Cartistem Phase 3 after surgery was selected as the best paper for 2021 by the American Journal of Sports Orthopedic Surgery (OJSM). This is the first of its kind in Korea....It contains long-term follow-up results for 48 weeks and 5 years after administration of 89 patients who participated in the Phase 3 clinical trial. As a result of 5-year long-term follow-up, the Cartistem test group compared to the microperforation control group, which are the efficacy evaluation indicators, such as knee pain and stiffness, improvement of physical function by progress (WOMAC), subjective pain relief (100mm VAS), improvement of joint function (IKDC). This was improved and maintained."

P3 data • CNS Disorders • Osteoarthritis • Pain

Medipost secured investment, spurs entry into US clinical and CGT markets for Cartistem [Google translation] (Newsway) - "According to the industry on the 14th, Medipost attracted a total of 140 billion won in third-party allocation-type private equity funds in March....In addition, CEO Yang plans to use the investment in US clinical trials for knee osteoarthritis treatment 'Cartistem' and injectable osteoarthritis treatment 'SMUP-IA-01' to speed up its entry into the US osteoarthritis treatment market."

Financing • CNS Disorders • Osteoarthritis • Pain

Medipost Visualizes Phase 3 Clinical Trial of Osteoarthritis Stem Cell Treatment ‘Cartistem’ in Japan [Google translation] (i24NEWS) - "Medipost will start phase 3 clinical trials in Japan of 'Cartistem', a stem cell treatment for osteoarthritis this year. In addition, Cartistem is spurring the development of next-generation osteoarthritis treatment....Cartistem...is planning to select a clinical hospital and conduct medication this year."

New P3 trial • CNS Disorders • Immunology • Osteoarthritis • Pain

Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus (clinicaltrials.gov) - P3; N=102; Active, not recruiting; Sponsor: Hyundai Bioland Co., Ltd.; Enrolling by invitation ➔ Active, not recruiting; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Enrollment closed • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • MRI

Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus (clinicaltrials.gov) - P3; N=100; Enrolling by invitation; Sponsor: SK bioland co., ltd.; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Musculoskeletal Diseases

Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus (clinicaltrials.gov) - P3; N=100; Enrolling by invitation; Sponsor: SK bioland co., ltd.

Clinical • New P3 trial • MRI

MediPost expects overseas expansion of treatment system Katstem -IBK investment (E-Today) - "The overseas clinical schedule has ended Phase I and Phase 2a of the US Food and Drug Administration (FDA) and is preparing for the next phase."

New trial

Japan OKs Medipost’s P2 trial of stem cell-serviced osteoarthritis treatment (Korea Biomedical Review) - "Medipost said Japan's Ministry of Health, Labour and Welfare has approved its phase 2 clinical trial of Cartistem, a stem-cell treatment for knee cartilage defects in patients with osteoarthritis caused by degenerative or recurrent trauma....'In the first half of next year, the company will also apply for phase 3 clinical trials targeting patients who do not need HTO [high tibial osteotomy] procedures.'"

Japanese regulatory • New P3 trial

[Interview] Medipost to unlock potential in regenerative medicine (KoreaTimes) - "In September, Medipost received the Ministry of Food and Drug Safety's approval for a phase 1 trial of SMUP-IA-01, and has been testing the drug with Seoul National University, finishing the first round of injections, Oct. 14....Medipost plans to roll out its existing Cartistem treatment in Japan. The company applied for phase 2 trials of the drug to Japan's Pharmaceuticals and Medical Devices Agency in November and expects to see it granted this week. In the U.S., it has finished phase 1/2a trials....It surpassed the 10 billion won mark in yearly sales in 2017 and more than 1,100 vials were sold in the first quarter of this year."

Japanese regulatory • Sales • Trial completion • Trial status

Medipost’s stem cell therapy, cord blood bank show solid growth (Korea Biomedical Review) - "Medipost’s stem cell therapy Cartistem for osteoarthritis and umbilical cord blood bank CellTree have pulled off two-digit sales growth in the first half. According to the company’s public filing on Wednesday, Cartistem sold 8.1 billion won ($6.7 million) in the first half, a 24.7 percent increase from 6.5 billion won a year earlier. The revenue from Cartistem accounted for 34.4 percent of the total sales in the first six months of 2019, 5.6 percentage points higher from 28.8 percent during the same period of last year."

Sales

Cartilage Regeneration in Osteoarthritic Patients by a Composite of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells and Hyaluronate Hydrogel: Results from a Clinical Trial for Safety and Proof-of-Concept with 7 Years of Extended Follow-Up. (PubMed, Stem Cells Transl Med) - "...The stem cell-based medicinal product (a composite of culture-expanded allogeneic hUCB-MSCs and hyaluronic acid hydrogel [Cartistem]) was applied to the lesion site...The application of this novel stem cell-based medicinal product appears to be safe and effective for the regeneration of durable articular cartilage in osteoarthritic knees. Stem Cells Translational Medicine 2017;6:613-621."

Journal