Trial Outcomes & Findings for Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFpEF Patients Treated With Allogeneic CDCs (NCT NCT02941705)

Last Updated: 2024-07-25

Results Overview

any subjects experiencing any safety related events during or post intracoronary delivery and during the follow up period. Safety outcomes will be measured through TIMI flow 0-2, acute myocarditis within one month of intracoronary infusion, ventricular tachycardia or ventricular fibrillation within 72 hours of intracoronary infusion, sudden unexpected death within 72 hours of intracoronary infusion defined as occurring 1 hour within in symptom onset or witnessed death in a subject previously observed to be well within the preceding 24 hours without an identified cause, or a major adverse cardiac event within 72 hours of intracoronary infusion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

one year

Results posted on

2024-07-25

Participant Flow

The proposed goal in the DOD application was a sample size of 40 patients. The actual enrolled number was 27. We were unable to reach the goal of 40 due to constraints in time, budget, and patient availability. In part these constraints were exaggerated by the COVID 19 pandemic (declared 3-1-2020) which severely constrained enrollment in all clinical trials in the USA. 2 subjects who were screen failures who were never consented. One was screened/enrolled but withdrew prior to cell infusion.

Participant milestones

Participant milestones
Measure	RECIEVED CELLS this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	CONTROL ARM this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regression of Fibrosis & Reversal of Diastolic Dysfunction in HFpEF Patients Treated With Allogeneic CDCs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RECIEVED CELLS n=13 Participants this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	CONTROL ARM n=13 Participants this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	11 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	13 participants n=93 Participants	13 participants n=4 Participants	26 participants n=27 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	RECIEVED CELLS n=13 Participants this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	CONTROL ARM n=13 Participants this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
the Safety Profile of CAP 1002; Any Subjects Experiencing Any Safety Related Events During or Post Intracoronary Delivery and During the Follow up Period.	0 Participants	1 Participants

Adverse Events

RECIEVED CELLS

Serious events: 3 serious events

Other events: 12 other events

Deaths: 1 deaths

CONTROL ARM

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RECIEVED CELLS n=13 participants at risk this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	CONTROL ARM n=13 participants at risk this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
Vascular disorders Ischemic Stroke	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Ear and labyrinth disorders Vertigo/sinus infection	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Atrial Fibrillation	15.4% 2/13 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Chronotropic incompetence/ pacemaker implanted	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.
Infections and infestations Cystitis	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.
Respiratory, thoracic and mediastinal disorders Acute HFpEF exacerbation	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic adenocarcinoma	7.7% 1/13 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.

Other adverse events

Additional Information

Russell Haber

Cedar Sinai

Phone: (310) 967-8322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	RECIEVED CELLS n=13 participants at risk this arm will receive the CDCs /CAP 1002 solution Allogeneic Derived Cells: patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.	CONTROL ARM n=13 participants at risk this arm will receive a solution during randomization but will not receive the CDCs Placebo/Control Arm: patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
Infections and infestations Acute Cystitis	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Respiratory, thoracic and mediastinal disorders Acute HFpEF Exac	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Renal and urinary disorders AKI	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.
Nervous system disorders Anxiety during RHC	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Atrial Fibrillation	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Atrial Tachycardia	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Musculoskeletal and connective tissue disorders Back Pain with Spinal Nerve Ablation	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Bradycardia	30.8% 4/13 • Number of events 4 • Adverse event data were collected over 1 year following infusion.	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.
Infections and infestations Bronchitis	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Chest Pain	15.4% 2/13 • Number of events 3 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Nervous system disorders Confusion	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Ear and labyrinth disorders Dizziness	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Anemia	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Elevated Bilirubin	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Elevated BNP	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Elevated Troponin	53.8% 7/13 • Number of events 7 • Adverse event data were collected over 1 year following infusion.	69.2% 9/13 • Number of events 9 • Adverse event data were collected over 1 year following infusion.
Gastrointestinal disorders Emesis	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Hyperglycemia	15.4% 2/13 • Number of events 3 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Hypervolemia	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Hypoglycemia	7.7% 1/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Hypotension	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Increased Swelling	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Infections and infestations Influenza	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Vascular disorders Ischemic Stroke	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Gastrointestinal disorders Laryngeal papillomas excision	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Nervous system disorders Memory Loss	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Nonflow Limiting Staining in Prox LCx	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Adenocarcinoma	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Gastrointestinal disorders Pancreatitis	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Endocrine disorders Potential Metabolic Acidosis	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Musculoskeletal and connective tissue disorders Right Knee Pain	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Surgical and medical procedures Skin tear from blood pressure cuff	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.
Nervous system disorders Syncopal Episode	15.4% 2/13 • Number of events 2 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Tachy Arrythmia	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Skin and subcutaneous tissue disorders Thrombophebitis of Right Arm	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Metabolism and nutrition disorders Transaminitis	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Cardiac disorders Transient AV Block during RCA infusion	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.
Infections and infestations Upper Respiratory Infection	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Renal and urinary disorders UTI	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.
Ear and labyrinth disorders Vertigo/Chronic Sinus Infection	0.00% 0/13 • Adverse event data were collected over 1 year following infusion.	7.7% 1/13 • Number of events 1 • Adverse event data were collected over 1 year following infusion.