HB-adMSC / Hope Biosciences - LARVOL DELTA

"HB-adMSCs for the Treatment of Patients With Multiple Sclerosis" (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: Hope Biosciences Research Foundation | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

Adipose-Derived Mesenchymal Stem Cells Improve Quality of Life in Patients with Relapsing-Remitting MS: Results from a Phase 2 Randomized Placebo-Controlled Trial (ECTRIMS 2025) - "HB-adMSC therapy is safe and effective in improving quality of life for MS patients. These findings support further research into HB-adMSCs as a potential MS treatment, emphasizing the need for larger, long-term studies to confirm sustained efficacy and safety. Disclousure of interest: Ridhima Vij: nothing to disclose; Hosu Kim: shareholder of Hope Biosciences LLC; Hyeonggeun Park: shareholder of Hope Biosciences LLC; Djamchid Lotfi: nothing to disclose; Thanh Cheng: nothing to disclose; Donna Chang: shareholder of Hope Biosciences LLC"

Clinical • HEOR • Late-breaking abstract • P2 data • CNS Disorders • Multiple Sclerosis

Hope Biosciences Secures FDA RMAT Designation for Stem Cell Therapy in Relapsing-Remitting Multiple Sclerosis (Businesswire) - "RMAT designation for HB-adMSCs in RRMS comes after positive top-line results in a Phase II clinical trial conducted at HBRF throughout 2023 and 2024, the first trial globally to administer pure mesenchymal stem cells to MS patients in such high quantities over repeat treatments. That trial (NCT05116540) was a balanced randomized, double-blind, single center study that enrolled 24 participants."

FDA event • Multiple Sclerosis

"HB-adMSCs for the Treatment of Patients With Multiple Sclerosis" (clinicaltrials.gov) - P2 | N=10 | Enrolling by invitation | Sponsor: Hope Biosciences | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • CNS Disorders • Multiple Sclerosis

"HB-adMSCs for the Treatment of Patients With Multiple Sclerosis" (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Hope Biosciences

New P2 trial • CNS Disorders • Multiple Sclerosis

Hope Biosciences Research Foundation Reports Promising Phase II Trial Results for Stem Cell Therapy in Multiple Sclerosis (Businesswire) - P2 | N=24 | HBMS01 (NCT05116540) | "The trial successfully met its primary endpoint, demonstrating statistically significant improvements in both physical and mental health for the treatment group compared to the placebo group...At end of study, the HB-adMSC group showed a statistically significant improvement from baseline in their Physical Health Composite Scores (p<0.0001) compared to the placebo group (p<0.4856). The effect size between the groups was large (Cohen’s d=1.23), with a significant overall treatment difference (p=0.0002). The HB-adMSC group also exhibited a significant improvement from baseline in their Mental Health Composite Scores (p<0.0042) compared to the placebo group (p<0.5724). The effect size was substantial (Cohen’s d=0.85), with a statistically significant overall treatment difference (p=0.016). Treatment was safe and tolerable in both groups."

P2 data • CNS Disorders • Immunology • Multiple Sclerosis

Autologous Adipose-Derived Mesenchymal Stromal Cells for Chronic Traumatic Brain Injury (ACS-CLINCON 2024) - " This was a Phase 1 study analyzing the safety and efficacy of HB-adMSC infusion with a single-arm design... This demonstrates autologous adipose-derived MSCs for chronic TBI is safe, has clinically relevant treatment effect sizes in functional and neurocognitive outcome measures, and reduces microglial activation in regions corresponding to pain, fatigue, and depression."

Stroma • CNS Disorders • Depression • Fatigue • Pain • Psychiatry • Vascular Neurology

Safety and efficacy of adipose-derived mesenchymal stem cell therapy in elderly Parkinson's disease patients: an intermediate-size expanded access program. (PubMed, Cytotherapy) - "The administration of autologous 200MM HB-adMSCs was found to be safe and well-tolerated in the elderly PD population. Although not achieving statistical significance, modest clinical improvements were noted across multiple secondary endpoints. These findings underscore the safety profile of the treatment in elderly patients and highlight the importance of evaluating clinical relevance alongside statistical measures for meaningful patient outcomes. Further investigation with a larger, randomized, placebo-controlled design is warranted to validate these observations."

Journal • CNS Disorders • Fatigue • Movement Disorders • Parkinson's Disease

Functional recovery of a 41-year-old quadriplegic spinal cord injury patient following multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells: a case report. (PubMed, Front Transplant) - "Multiple intravenous infusions of autologous HB-adMSCs for treatment of SCI demonstrated significant enhancements in the patient's neurological function with improved quality-of-life. Further research is needed to evaluate the results of this study."

Journal • CNS Disorders • Musculoskeletal Diseases • Orthopedics • Transplantation

HBMS01: Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: Hope Biosciences Stem Cell Research Foundation | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=51 | Recruiting | Sponsor: Hope Biosciences | Enrolling by invitation ➔ Recruiting

Enrollment status • CNS Disorders • Vascular Neurology

HBMS01: Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Hope Biosciences Stem Cell Research Foundation | Trial completion date: Nov 2023 ➔ Jul 2024 | Trial primary completion date: Nov 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=51 | Enrolling by invitation | Sponsor: Hope Biosciences | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • CNS Disorders • Vascular Neurology

Adipose-derived, autologous mesenchymal stem cell therapy for patients with post-COVID-19 syndrome: an intermediate-size expanded access program. (PubMed, Stem Cell Res Ther) - P=N/A | "The results of the expanded access program indicated that treatment with autologous HB-adMSCs resulted in significant improvements in the signs and symptoms associated with post-COVID-19 syndrome as assessed by VAS and FAS scores. Additionally, improvements in the patients' quality-of-life as demonstrated using SF-36 scores that also showed significant improvements in individual scaled scores. Overall, administration of multiple infusions of autologous HB-adMSCs is safe and efficacious for improvements in the quality-of life of patients with post-COVID-19 syndrome."

Journal • Fatigue • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease

Intermediate Size Expanded Access Protocol Using Autologous HB-adMSCs for the Treatment of Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: Hope Biosciences Stem Cell Research Foundation

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury (clinicaltrials.gov) - P2 | N=51 | Not yet recruiting | Sponsor: Hope Biosciences

New P2 trial • CNS Disorders • Vascular Neurology • IL10 • IL1A • IL4 • IL6 • TNFA

HBMS01: Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Hope Biosciences Stem Cell Research Foundation | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: Hope Biosciences Stem Cell Research Foundation | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Feb 2023 | Trial primary completion date: May 2023 ➔ Feb 2023

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Hope Biosciences | Active, not recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Vascular Neurology • IL10 • IL1A • IL4 • IL6 • TNFA

HBMS01: Randomized Double-Blind Phase 2 Efficacy and Safety of Autologous HB-MSCs vs Placebo for Treatment of Multiple Sclerosis (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Hope Biosciences Stem Cell Research Foundation

Clinical • New P2 trial • CNS Disorders • Multiple Sclerosis

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate) (clinicaltrials.gov) - P2; N=24; Active, not recruiting; Sponsor: Hope Biosciences Stem Cell Research Foundation; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

PD: Parkinson's Disease (Early and Moderate) (clinicaltrials.gov) - P2; N=24; Recruiting; Sponsor: Hope Biosciences Stem Cell Research Foundation

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: Hope Biosciences; N=24 ➔ 0; Active, not recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Alzheimer's Disease • CNS Disorders • CRP • IL6 • TNFA

SCI04: HB-adMSCs for the Treatment of Spinal Cord Injury (clinicaltrials.gov) - P; N=N/A; Temporarily Not Available; Sponsor: Hope Biosciences Stem Cell Research Foundation

Clinical • New trial • CNS Disorders • Complement-mediated Rare Disorders • Orthopedics

Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P; N=N/A; Temporarily Not Available; Sponsor: Hope Biosciences Stem Cell Research Foundation

Clinical • New trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus