MSCTC-0010 / IMAC Holdings - LARVOL DELTA

A Phase Ib Study to Expand on the Safety of Wharton’s Jelly Mesenchymal Stem Cells for Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease (TCT-ASTCT-CIBMTR 2025) - "Conclusions : MSCTC-0010 appears to be safe and well-tolerated in an exceptionally high-risk patient population. These data support advancement of MSCTC-0010 to a pivotal Phase 2 trial in high risk and steroid refractory aGvHD patients."

Clinical • P1 data • Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Oncology

Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Kansas Medical Center | Trial completion date: Aug 2023 ➔ Aug 2025 | Trial primary completion date: Aug 2023 ➔ Aug 2025

Trial completion date • Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: University of Kansas Medical Center | Trial primary completion date: Aug 2022 ➔ Aug 2023

Preclinical • Trial primary completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

IMAC Holdings, Inc. Announces Initiation of Third and Final Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (BioSpace) - "IMAC Holdings, Inc...today announces it has initiated the third and final cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease."

Trial status • CNS Disorders • Parkinson's Disease

IMAC Holdings, Inc. Announces Completion of Second Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (GlobeNewswire) - "IMAC Holdings... today announces it has completed the second cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease....In accordance with the trial protocol, the Company will wait at least 30 days to demonstrate safety of the medium concentration dose before initiating the third and final cohort in which five patients will receive a high concentration intravenous dose of stem cells."

Trial status • CNS Disorders • Parkinson's Disease

IMAC Holdings, Inc. Announces Initiation of Second Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (GlobeNewswire) - "IMAC Holdings...announces it has initiated the second cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease."

Trial status • CNS Disorders • Parkinson's Disease

A Phase I Study to Elevate the Safety of Wharton's Jelly Mesenchymal Stem Cell for the Treatment of De Novo High Risk or Steroid Refactory Acute Graft Versus Host Disease (aGVHD) - P1, N=10; "Analysis of these two biomarkers showed a reduction from day 0 to day 42. Subjects who received the higher dose of MSCTC-0010 had a statistically significant decline in the Reg-3 α levels on day 7, 14, 21, and 28. The drop in levels correlated with the clinical response. ST-2 levels showed a significant decrease on day 28 and 42. Conclusion This Phase 1 trial with MSCTC-0010 successfully met its primary endpoint of safety. Treatment with MSCTC-0010 shows promise in patients with high risk aGvHD."

P1 data

Evaluation of Umbilical Cord-Derived Wharton's Jelly Stem Cells for the Treatment of Acute Graft Versus Host Disease (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: University of Kansas Medical Center; Active, not recruiting ➔ Recruiting; Trial completion date: Aug 2020 ➔ Aug 2023; Trial primary completion date: Aug 2020 ➔ Aug 2022

Enrollment open • Preclinical • Trial completion date • Trial primary completion date • Graft versus Host Disease • Immunology

IMAC Holdings, Inc. Announces Completion of First Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (GlobeNewswire) - "IMAC Holdings...today announces it has completed the first cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease...In accordance with the trial protocol, the Company will wait at least 30 days to demonstrate safety of the low dose before initiating the second cohort in which five patients will receive a medium intravenous dose."

Trial status • CNS Disorders • Parkinson's Disease

Dosing Begins in Phase 1 Trial of Stem Cell Therapy for Bradykinesia (Parkinson's News Today) - "A first patient has been dosed in IMAC Holdings’ Phase 1 clinical trial evaluating its investigational umbilical cord-derived mesenchymal stem cells (MSCs) as a potential treatment for bradykinesia, a common motor symptom of Parkinson’s disease...We anticipate full patient enrollment by the end of February 2021, with subsequent infusions continuing in early 2021."

Enrollment status • Trial status • CNS Disorders • Parkinson's Disease

Evaluate Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells for the Treatment of Bradykinesia (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: IMAC Holdings, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Sep 2020 ➔ Dec 2020

Clinical • Enrollment open • Trial initiation date

IMAC Holdings, Inc. Announces Opening Enrollment in Its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (GlobeNewswire) - "IMAC Holdings, Inc....today announces it is opening enrollment in its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual slowing and loss of spontaneous body movement, due to Parkinson’s disease....The enrollment process and the subsequent first dose is expected to be administered by the end of 2020....'We look forward to the opportunity to share the outcome from the trial in the coming year.'"

Enrollment open • CNS Disorders • Parkinson's Disease

A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease. (PubMed, Stem Cell Rev Rep) - "Treatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 10 cells/ kg dose be tested in an expanded randomized, controlled Phase 2 trial. Graphical abstract."

Journal • P1 data • Graft versus Host Disease • Immune Modulation • Immunology • Inflammation • Transplantation

IMAC Holdings Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment of Bradykinesia Due to Parkinson’s Disease (GlobeNewswire) - "IMAC Holdings, Inc...today announced the United States Food and Drug Administration (the'FDA') approved its investigational new drug application...for the use of umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia, or the gradual loss and slowing down of spontaneous body movement, due to Parkinson’s disease...will now initiate enrollment of 15 patients for its phase 1 trial."

IND • New P1 trial • CNS Disorders • Parkinson's Disease