Drugs / autologous bone marrow mononuclear cells
autologous bone marrow mononuclear cells
also known as
BMMNCs · BMMC · autologous bone marrow-derived mononuclear cells · CardiAMP cell therapy · MNCs
Trials 23
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | BioCardia, Inc. | Regulatory June 05 - FDA Confirms CardiAMP HF II May Support Premarket Approval Of CardiAMP Cell Therapy For Ischemic HFrEF biocardia.com ↗
The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. |
| 2026-05-28 | BioCardia, Inc. | Regulatory May 28 - BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure biocardia.com ↗
today reported the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF. |
| 2026-05-21 | BioCardia, Inc. | Results May 21 - BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina Frequency biocardia.com ↗
Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. |
| 2026-04-20 | BioCardia, Inc. | Regulatory April 20 - BioCardia And Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure biocardia.com ↗
PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. |
| 2026-03-17 | BioCardia, Inc. | Results March 17 - BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure biocardia.com ↗
For the CardiAMP HF trial subgroup with elevated biomarkers of heart stress, the cells delivered have shown meaningful benefit for these higher-risk patients already on stable American Heart Association and American College of Cardiology guideline directed medical therapy. |
| 2026-03-03 | BioCardia, Inc. | Results March 03 - BioCardia Late Breaking Echocardiography Clinical Results from CardiAMP HF Trial Presented at Technology and Heart Failure Therapeutics (THT) biocardia.com ↗
Dr. Raval reported that patients receiving the autologous CardiAMP cell therapy under investigation demonstrated positive evidence of decreased pathological left ventricular remodeling over time compared to patients not receiving the treatment. |
| 2025-09-18 | BioCardia, Inc. | Results BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up biocardia.com ↗
Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. |
| 2025-03-31 | BioCardia, Inc. | Results BioCardia Phase 3 CardiAMP-HF Trial Of Novel Cardiac Cell Therapy For Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, And Improved Quality Of Life At Two Years biocardia.com ↗
In this rigorous CardiAMP-HF Trial, patients who received the novel cell therapy adjunctive to medication experienced decreased mortality and MACCE, with improved quality of life, when compared to those on medication alone. |
| 2024-08-21 | BioCardia, Inc. | Regulatory FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment biocardia.com ↗
BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the FDA has approved a protocol amendment for the CardiAMP Heart Failure II Trial, BioCardia’s confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF). |
| 2024-05-01 | BioCardia, Inc. | Results BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes biocardia.com ↗
All of the patients responded positively to therapy, as measured by increased (improved) exercise tolerance and greatly reduced angina. |
| 2024-03-12 | BioCardia, Inc. | Regulatory BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study biocardia.com ↗
CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. |
| 2024-03-04 | BioCardia, Inc. | Results BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure biocardia.com ↗
Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. |
| 2023-11-14 | BioCardia, Inc. | Regulatory BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure biocardia.com ↗
BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol. |
| 2023-10-11 | BioCardia, Inc. | Results BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II biocardia.com ↗
Notably, patients receiving CardiAMP Cell Therapy followed up to 24 months showed a 37% relative risk reduction of cardiac death equivalents and an 18% relative risk reduction in major adverse cardiac and cerebrovascular events (MACCE). |
| 2023-09-05 | BioCardia, Inc. | Results BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial biocardia.com ↗
For the first-tier, all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement at 12 months there were 5.6% of CardiAMP treatment patients versus 5.3% for the control group (p = 0.42). |
| 2023-07-05 | BioCardia, Inc. | Regulatory BioCardia Completes Submission of CardiAMP Cell Therapy System in Heart Failure to Japan’s Pharmaceutical Medical Device Agency biocardia.com ↗
Sunnyvale, Calif. – BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it completed its submission of the CardiAMP Cell Therapy System to Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF[DM1] [PA2] ). |
| 2023-06-20 | BioCardia, Inc. | Regulatory BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study biocardia.com ↗ |
| 2023-03-06 | BioCardia, Inc. | Results Positive Echocardiography Data from BioCardia Phase III CardiAMP Cell Therapy Heart Failure Trial Presented at American College of Cardiology Annual Meeting biocardia.com ↗
The echocardiography results from baseline through one and two years showed a more than doubling in the number of heart segments functioning normally and restoration of function to 30 percent of previously non-functioning segments. |
All press releases naming this drug 25 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Autologous Bone Marrow Mononuclear Cells | “OBJECTIVE: To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering...” PMID 32393654 ↗ May 202022“Direct injection of autologous bone marrow mononuclear cells into the myocardium may result in improved functional recovery, relieve symptoms, and improve other cardiovascular outcomes.” PMID 29803986 ↗ Apr 2018 “In this study, the effect of intrathecal administration of autologous bone marrow mononuclear cells (BMMNCs) is analyzed on the recovery process of patients with chronic stroke.” PMID 25126443 ↗ Jul 2014 “The intervention group underwent cellular transplantation consisting of intrathecal administration of autologous bone marrow mononuclear cells and standard neurorehabilitation.” PMID 29386049 ↗ Jan 2018 “Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.” NCT02009124 ↗ “The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.” NCT02241395 ↗ “Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.” NCT02027246 ↗ “Transplantation of Autologous Bone Marrow Mononuclear Cells” NCT03123562 ↗ “Transplantation of Autologous Bone Marrow Mononuclear cells” NCT05472428 ↗ “Transplantation of Autologous Bone Marrow Mononuclear Cells” NCT04080921 ↗ “Transplantation of Autologous Bone Marrow Mononuclear cells” NCT03225651 ↗ |
| Known as | autologous bone marrow-derived mononuclear cells | “autologous bone marrow-derived mononuclear cells (BMMC)” NCT00832247 ↗ |
| Known as | BMMC | “autologous bone marrow-derived mononuclear cells (BMMC)” NCT00832247 ↗1“autologous bone marrow mononuclear cell (BMMC)” PMID 31438885 ↗ Aug 2019 |
| Known as | BMMNCs | “Additionally, intrathecal infusion of autologous bone marrow mononuclear cells (BMMNCs) led to a slight decrease in TGF-β and GDF-15 levels in the CSF of ASD and CP patients,...” PMID 38114596 ↗ Dec 20234“In this study, the effect of intrathecal administration of autologous bone marrow mononuclear cells (BMMNCs) is analyzed on the recovery process of patients with chronic stroke.” PMID 25126443 ↗ Jul 2014 “bone marrow derived mononuclear cells (BM-MNCs) transplantation” PMID 25678991 ↗ Oct 2014 “autologous bone marrow mononuclear cells (BM MNCs)” PMID 30107811 ↗ Aug 2018 “autologous bone marrow mononuclear cells (BMMNCs)” NCT01575470 ↗ |
| Known as | CardiAMP cell therapy | “treatment with the CardiAMP cell therapy” NCT02438306 ↗ |
| Known as | MNCs | “OBJECTIVE: To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering...” PMID 32393654 ↗ May 2020 |
| Modality | Cell therapy | “cellular therapy” NCT00832247 ↗ |
| Route | Intravenous | “infused through a peripheral vein” NCT00832247 ↗ |