Trial Outcomes & Findings for Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD (NCT NCT02887859)

NCT ID: NCT02887859

Last Updated: 2025-04-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-04-18

Participant Flow

A total of 20 patients were screened, and 15 patients received the HAV at 6 study centers in the United States of America.

Participant milestones

Measure	HAV Treatment Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Overall Study STARTED	15
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	HAV Treatment Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Overall Study Ongoing	6
Overall Study Adverse Event	7
Overall Study Death	1
Overall Study Physician Decision	1

Baseline Characteristics

Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

Baseline characteristics by cohort

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Age, Customized >54 and <75 years	15 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI)	29.0 kg/m^2 STANDARD_DEVIATION 6.00 • n=5 Participants
Weight	81.5 kg STANDARD_DEVIATION 13.81 • n=5 Participants
Height	168.6 cm STANDARD_DEVIATION 11.48 • n=5 Participants
Smoking History Former	11 Participants n=5 Participants
Smoking History Current	4 Participants n=5 Participants
Smoking History Never	0 Participants n=5 Participants
Pack years	24.2 Pack years STANDARD_DEVIATION 12.46 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site Number of Participants with aneurysm formation	0 Participants
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site Number of Participants with Anastomotic bleeding or spontaneous rupture	0 Participants
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site Number of Participants with HAV infection	0 Participants
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site Number of Participants with HAV removal	0 Participants
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site Number of Participants with Significant inflammation at the HAV implantation site	0 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With Adverse Events Number of Participants with Any AE	15 Participants
Number of Participants With Adverse Events Number of Participants with Mild AEs	11 Participants
Number of Participants With Adverse Events Number of Participants with Moderate AEs	13 Participants
Number of Participants With Adverse Events Number of Participants with Severe AEs	12 Participants
Number of Participants With Adverse Events Number of Participants with Life-threatening AEs	0 Participants
Number of Participants With Adverse Events Number of Participants with Death	1 Participants

PRIMARY outcome

Timeframe: 12 months

Population: One patient died prior to the Month 12 visit.

Primary patency = patent ("open" to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions

Outcome measures

Measure	HAV Treatment n=14 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Primary Patency at Month 12 · Yes	6 Participants
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Primary Patency at Month 12 · No	8 Participants
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Primary Assisted Patency at Month 12 · Yes	8 Participants
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Primary Assisted Patency at Month 12 · No	6 Participants
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Secondary Patency at Month 12 · Yes	9 Participants
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary) Number of Participants with Secondary Patency at Month 12 · No	5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: One patient did not complete Month 6 visit due to COVID-19-related hospital restrictions; One patient was not assessed at the scheduled Month 9 visit; One patient died prior to the Month 9 visit.

Outcome measures

Measure	HAV Treatment n=14 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis: Month 6	2 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis: Month 9	1 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis: Month 12	0 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in Proximal Anastomosis	2 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in Distal Anastomosis	1 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in Immediate Inflow Artery	0 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in HAV Bypass	0 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in Immediate Outflow Artery	0 participants
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria) Number of Participants with Hemodynamically Significant Stenosis in Presence of Aneurysm	0 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=14 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With a Change in Panel Reactive Antibodies (PRA) From Baseline	0 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Hematology Parameters - Hemoglobin Hemoglobin (g/dL)	13.40 g/dL Standard Deviation 1.69
Changes From Baseline in Hematology Parameters - Hemoglobin Hemoglobin (g/dL) Change From Baseline	0.07 g/dL Standard Deviation 1.24

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR) International Normalized Ratio (INR)	0.983 ratio Standard Deviation 0.067
Changes From Baseline in Coagulation Parameters - International Normalized Ratio (INR) INR Change From Baseline	-0.080 ratio Standard Deviation 0.094

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium Sodium (mmol/L)	138.3 mmol/L Standard Deviation 3.6
Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium Sodium (mmol/L) Change From Baseline	-0.1 mmol/L Standard Deviation 2.0
Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium Potassium (mmol/L)	4.51 mmol/L Standard Deviation 0.34
Changes From Baseline in Clinical Chemistry Parameters - Sodium, Potassium Potassium (mmol/L) Change From Baseline	0.25 mmol/L Standard Deviation 0.32

SECONDARY outcome

Timeframe: 12 months

e.g., angioplasty, thrombectomy, surgical revision

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Number of Participants With HAV Interventions Number of Participants with HAV intervention due to anastomotic or mid-HAV stenosis	2 participants
Number of Participants With HAV Interventions NUmber of Participant with HAV intervention proximal to the HAV to treat arterial inflow obstruction	1 participants

SECONDARY outcome

Timeframe: 12 months

Population: Mean total VascuQol score at 12 months. One patient died prior to the Month 12 visit.

scoring per Vascular Quality of Life Questionnaire (VascuQoL) Likert scale: 7, there is 1 (the worst) to 7 (the best possible)

Outcome measures

Measure	HAV Treatment n=14 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Mean Vascular Quality of Life Questionnaire (VascuQoL) Score (1-7) for Patients With PAD Symptoms	5.9 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 12 months

Normal: 1.0 - 1.4 Borderline: 0.9 - 1.0 Mild PAD (peripheral artery disease): 0.8 - 0.9 Moderate PAD: 0.4 - 0.7 Severe PAD: < 0.4

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Ankle Brachial Index (ABI)	0.902 units on a scale Standard Deviation 0.150

SECONDARY outcome

Timeframe: 12 months

Population: One patient did not complete the test. One patient died prior to the Month 12 visit.

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Six Minute Walk Test - Duration Duration (Minutes)	6.0 minutes Standard Deviation 0
Six Minute Walk Test - Duration Change in Duration From Baseline	0.472 minutes Standard Deviation 1.154

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Hematology Parameters - Hematocrit Hematocrit (%)	41.69 percentage Standard Deviation 4.65
Changes From Baseline in Hematology Parameters - Hematocrit Hematocrit (%) Change From Baseline	1.20 percentage Standard Deviation 3.78

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Lymphocytes Count (x 10^3/uL)	2.459 cells x 10^3/uL Standard Deviation 0.931
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Lymphocytes Count (x 10^3/uL) Change From Baseline	-0.186 cells x 10^3/uL Standard Deviation 0.450
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Monocytes Count (x 10^3/uL)	0.623 cells x 10^3/uL Standard Deviation 0.133
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Monocytes Count (x 10^3/uL) Change From Baseline	0.004 cells x 10^3/uL Standard Deviation 0.207
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Eosinophils Count (x 10^3/uL)	0.257 cells x 10^3/uL Standard Deviation 0.210
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Eosinophils Count (x 10^3/uL) Change From Baseline	0.073 cells x 10^3/uL Standard Deviation 0.139
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Basophils Count (x 10^3/uL)	0.046 cells x 10^3/uL Standard Deviation 0.017
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Basophils Count (x 10^3/uL) Change From Baseline	0.009 cells x 10^3/uL Standard Deviation 0.012
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts White Blood Cells (x 10^3/uL)	8.399 cells x 10^3/uL Standard Deviation 2.545
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts White Blood Cells (x 10^3/uL) Change From Baseline	-0.212 cells x 10^3/uL Standard Deviation 2.103
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Neutrophils Count (x 10^3/uL)	5.079 cells x 10^3/uL Standard Deviation 1.690
Changes From Baseline in Hematology Parameters - Lymphocytes, Monocyte, Eosinophil, Basophil, White Blood Cell, and Neutrophil Counts Absolute Neutrophils Count (x 10^3/uL) Change From Baseline	0.046 cells x 10^3/uL Standard Deviation 1.725

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time Activated Partial Thromboplastin Time (sec)	27.26 seconds Standard Deviation 3.54
Changes From Baseline in Coagulation Parameters - Activated Partial Thromboplastin Time Activated Partial Thromboplastin Time (sec) Change From Baseline	0.18 seconds Standard Deviation 2.14

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Calcium (mg/dL)	9.38 mg/dL Standard Deviation 0.43
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Calcium (mg/dL) Change From Baseline	0.28 mg/dL Standard Deviation 0.51
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose BUN (mg/dL)	20.9 mg/dL Standard Deviation 17.2
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose BUN (mg/dL) Change From Baseline	8.7 mg/dL Standard Deviation 16.3
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Total Bilirubin (mg/dL)	0.51 mg/dL Standard Deviation 0.21
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Total Bilirubin (mg/dL) Change From Baseline	-0.02 mg/dL Standard Deviation 0.25
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Creatinine (mg/dL)	1.118 mg/dL Standard Deviation 0.471
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Creatinine (mg/dL) Change From Baseline	0.188 mg/dL Standard Deviation 0.429
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Glucose (non-fasting) (mg/dL)	110.1 mg/dL Standard Deviation 44.2
Changes From Baseline in Clinical Chemistry Parameters - Calcium, BUN, Bilirubin, Creatinine, Glucose Glucose (non-fasting) (mg/dL) Change From Baseline	0.9 mg/dL Standard Deviation 29.6

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Changes From Baseline in Clinical Chemistry Parameters - Albumin Albumin (g/dL)	3.93 g/dL Standard Deviation 0.29
Changes From Baseline in Clinical Chemistry Parameters - Albumin Albumin (g/dL) Change From Baseline	0.39 g/dL Standard Deviation 0.80

SECONDARY outcome

Timeframe: 12 months

Population: One patient did not complete the test. One patient died prior to the Month 12 visit.

Outcome measures

Measure	HAV Treatment n=15 Participants Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Six Minute Walk Test - Distance Distance (in)	362.514 inch Standard Deviation 143.545
Six Minute Walk Test - Distance Change in Distance From Baseline	162.049 inch Standard Deviation 164.127

SECONDARY outcome

Timeframe: 12 months

Population: Removal of the HAV would be applicable if there were an indication (e.g., HAV-related complication) for surgical explantation; in this study there were no HAV-related complications warranting the need for surgical excision/removal.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 months

Outcome measures

Outcome data not reported

Adverse Events

HAV Treatment

Serious events: 11 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Measure	HAV Treatment n=15 participants at risk Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Blood and lymphatic system disorders Anemia	6.7% 1/15 • Number of events 1 • 12 months
Cardiac disorders Cardiac failure acute	6.7% 1/15 • Number of events 1 • 12 months
Gastrointestinal disorders Gastrointestinal hemorrhage	6.7% 1/15 • Number of events 1 • 12 months
General disorders Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis	26.7% 4/15 • Number of events 5 • 12 months
Infections and infestations Corona virus infection	6.7% 1/15 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Anastomic stenosis, Arterial bypass stenosis, Arterial bypass thrombosis, continued in description	60.0% 9/15 • Number of events 15 • 12 months
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	6.7% 1/15 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	6.7% 1/15 • Number of events 1 • 12 months
Renal and urinary disorders Acute kidney injury	6.7% 1/15 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pleural effusion, Respiratory failure	13.3% 2/15 • Number of events 2 • 12 months
Vascular disorders Arterial insufficiency	6.7% 1/15 • Number of events 1 • 12 months

Other adverse events

Measure	HAV Treatment n=15 participants at risk Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
Blood and lymphatic system disorders Lymphadenopathy	6.7% 1/15 • Number of events 1 • 12 months
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 12 months
Cardiac disorders Angina pectoris, Coronary artery disease	13.3% 2/15 • Number of events 2 • 12 months
General disorders Implant site extravasation, Peripheral swelling	26.7% 4/15 • Number of events 5 • 12 months
Hepatobiliary disorders Cholecystitis	6.7% 1/15 • Number of events 1 • 12 months
Infections and infestations Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection	26.7% 4/15 • Number of events 7 • 12 months
Injury, poisoning and procedural complications Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition	13.3% 2/15 • Number of events 2 • 12 months
Investigations Pulse absent, Scan myocardial perfusion abnormal	13.3% 2/15 • Number of events 2 • 12 months
Metabolism and nutrition disorders Gout, Hyperuricaemia, Vitamin B12 deficiency	20.0% 3/15 • Number of events 3 • 12 months
Musculoskeletal and connective tissue disorders Arthralgia, Back pain, Muscle necrosis, Musculoskeletal pain, Pain in extremity, Tenosynovitis	66.7% 10/15 • Number of events 12 • 12 months
Nervous system disorders Dizziness, Headache, Neuralgia	20.0% 3/15 • Number of events 3 • 12 months
Psychiatric disorders Anxiety, Insomnia	13.3% 2/15 • Number of events 2 • 12 months
Renal and urinary disorders Renal cyst	6.7% 1/15 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Cough, Pleural effusion, Pulmonary mass	26.7% 4/15 • Number of events 4 • 12 months
Skin and subcutaneous tissue disorders Dermatitis, Skin hyperpigmentation, Skin ulcer	20.0% 3/15 • Number of events 3 • 12 months
Vascular disorders Arterial stenosis, Haematoma, Intermittent claudication, Continued in description	60.0% 9/15 • Number of events 13 • 12 months

Additional Information

Dr. Shamik Parikh, MD, CMO

Humacyte Inc.

Phone: 919-313-9633

Email: sparikh@humacyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER