Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (17)

Adverse events (AEs)
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) graded using CTCAE Version 6.0, and incidence of treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Baseline through 12 months
Phase 1b: Dose-limiting toxicities (DLTs)
Incidence of DLTs and and participant stopping-rule events during Phase 1b safety review period prior to Phase 2a expansion
Baseline through Day 28
Number of Participants With Clinically Significant Changes From Baseline in Hematology Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in hematology laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Hematology assessments include protocol-specified parameters such as hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Participants with one or more clinically significant hematology abnormalities will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Serum Chemistry Laboratory Parameters
Number of participants with at least one clinically significant change from baseline in serum chemistry laboratory parameters, as determined by the investigator based on the laboratory reference range, magnitude of change from baseline, and clinical relevance. Serum chemistry assessments include protocol-specified measures of renal function, hepatic function, electrolytes, glucose, and other chemistry parameters. Participants with one or more clinically significant serum chemistry abnormalities will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant ECG Abnormalities
Number of participants with at least one clinically significant electrocardiogram abnormality, as determined by the investigator. ECG assessment will include heart rate, PR interval, QRS duration, QT interval, and corrected QT interval (QTc). Participants with one or more clinically significant ECG abnormalities will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Systolic Blood Pressure
Number of participants with a clinically significant change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Diastolic Blood Pressure
Number of participants with a clinically significant change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg), as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Heart Rate
Number of participants with a clinically significant change from baseline in heart rate, measured in beats per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Respiratory Rate
Number of participants with a clinically significant change from baseline in respiratory rate, measured in breaths per minute, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Peripheral Oxygen Saturation
Number of participants with a clinically significant change from baseline in peripheral oxygen saturation (SpO2), measured as percent oxygen saturation by pulse oximetry, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Number of participants with at least one new or worsened clinically significant abnormal finding identified during physical examination after study treatment, as determined by the investigator. Participants with multiple clinically significant physical examination findings will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FEV1
Number of participants with a clinically significant change from baseline in pre-dose forced expiratory volume in 1 second (FEV1), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FEV1
Number of participants with a clinically significant change in forced expiratory volume in 1 second (FEV1) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Baseline in Pre-Dose FVC
Number of participants with a clinically significant change from baseline in pre-dose forced vital capacity (FVC), measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Clinically Significant Changes From Pre-Dose to Post-Dose FVC
Number of participants with a clinically significant change in forced vital capacity (FVC) from the pre-dose measurement to the protocol-specified post-dose measurement, measured in liters by spirometry, as determined by the investigator based on the magnitude of change and clinical relevance.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Treatment-Emergent Hypersensitivity Reactions
Number of participants experiencing at least one treatment-emergent hypersensitivity reaction during or following administration of study treatment. Hypersensitivity reactions will be identified by the investigator based on protocol-defined clinical signs and symptoms, including allergic or systemic hypersensitivity manifestations. Participants experiencing more than one hypersensitivity reaction will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months
Number of Participants With Treatment-Emergent Inhalation-Related Reactions
Number of participants experiencing at least one treatment-emergent respiratory or inhalation-related reaction during or following nebulized study treatment. Reactions may include protocol-defined respiratory signs or symptoms such as cough, wheezing, chest tightness, dyspnea, bronchospasm, or clinically significant oxygen desaturation. Participants experiencing more than one inhalation-related reaction will be counted once for this outcome measure.
Baseline, Day 28, 3 months, 6 months, 12 months

Secondary Outcomes (17)

Spirometry
Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Baseline, Day 28, 3 months, 6 months, 12 months
Spirometry
Baseline, Day 28, 3 months, 6 months, 12 months
+12 more secondary outcomes

Study Arms (2)

Safety Cohort (Phase 1b)

EXPERIMENTAL

Participants receive 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells). Safety and tolerability are reviewed by an independent DSMC through Day 28 prior to Phase 2a enrollment.

Biological: Stem cells

Expansion Cohort (Phase 2a)

EXPERIMENTAL

Participants receive the same treatment regimen as Cohort 1: 2.4 billion SMS cells by oral inhalation via vibrating mesh nebulizer on Days 1, 3, and 6 (total: 7.2 billion cells), following DSMC review of Phase 1b safety data.

Biological: Stem cells

Interventions

Stem cellsBiological

The suspension of Small Mobile Stem (SMS) cells will be placed into a medical nebulizer machine, commonly used to deliver medicines into the lungs through inhalation. Participants with moderate to severe chronic obstructive pulmonary disease (COPD) will breathe in the mist containing the SMS cells through a mouthpiece. The treatment will be given at the study site on Days 1, 3, and 6. Each treatment will contain 2.4 billion SMS cells and will take approximately 30 minutes to complete. This is a Phase 1b/2a study designed to evaluate the safety, tolerability, and potential effects of SMS cells in people with moderate to severe COPD.

Also known as: Small Molecule Stem (SMS) Cells

Expansion Cohort (Phase 2a)Safety Cohort (Phase 1b)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult \>18 yrs old (inclusive).
Female participants:

Sponsors & Collaborators

SMSbiotech
Industrylead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Research Project Manager, MPHCONTACT305-243-6388

Trishul Siddharthan, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spermine SynthaseCell Count

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferases

Study Officials

Trishul Siddharthan, Medical Doctor
University of Miami
PRINCIPAL INVESTIGATOR

Central Study Contacts

Chief Clinical Officer

CONTACT

+1 info@smsbiotech.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

October 13, 2026

Study Start

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

October 2027

Estimated

You may not qualify if:

Previous or current diagnosis of COPD-G, COPD-D, COPD-I, COPD-A, or COPD-U; asthma, congestive heart failure, bronchiectasis, tuberculosis, obliterative bronchiolitis, or diffuse panbronchiolitis.
Previous or current history of respiratory failure other than due to COPD (e.g., restrictive lung disease, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, CMV pneumonitis, cystic fibrosis, asbestosis, silicosis, or farmer's lung disease), or detection of any of these conditions through screening CT scanning.
History of COVID-associated pneumonia with hypoxemic respiratory failure in the 12 weeks prior to screening.
Current use, or use within 21 days of screening, of systemic or inhaled corticosteroids. Participants on inhaled corticosteroids or combined inhaled therapies can be included; however, they must schedule inhaled therapies 12 hours prior to dosing IP and 12 hours post-dosing IP.
History of chronic renal insufficiency, defined as an eGFR \< 90 mL/min/1.73 m² \[3\] and/or defined as abnormalities of kidney structure or function, present for \>3 months. Participants without a history of chronic renal insufficiency, who at screening have an eGFR detected between 60-89 mL/min/1.73 m², may be enrolled and receive IP per the investigator's discretion.
Uncontrolled hypertension, or current hypertension controlled on more than two medications.
History of coronary artery disease, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, severe peripheral arterial disease, cerebrovascular disease (including history of transient ischemic attack or cerebrovascular accident).
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c \> 7.5%) at screening.
History or active malignancy, including any potential neoplasm detected via high-resolution CT scan (nodule \> 5 mm) detected as part of the screening process.
People with a history of basal cell or squamous cell carcinoma of the skin are eligible.
History of HIV or other immunosuppressed conditions, Hepatitis B or Hepatitis C, or use of immunosuppressive medications within 14 days prior to screening, and for 3 weeks after the last dose of study intervention is administered.
Active infection requiring systemic antibiotic treatment within 12 weeks prior to screening.
Body mass index (BMI) \> 60 kg/m2.
Active smoking of tobacco, cannabis or vaping in the 28 days prior to screening as indicated by results of cotinine urine testing, performed at screening. Use of nicotine containing products such as nicotine patches, oral nicotine products or nicotine chewing gum is permitted, noting that cotinine results will be positive. Positive results will be documented by the investigator as: "attributed to permitted nicotine products".
History of alcohol or other substance abuse, with sobriety less than one year, or that in the opinion of the investigator, will impact participation in the study.
+6 more criteria

A Study to Investigate Small Mobile Stem Cells (SMS) in Moderate to Severe Chronic Obstructive Pulmonary Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (17)

Secondary Outcomes (17)

Study Arms (2)

Safety Cohort (Phase 1b)

Expansion Cohort (Phase 2a)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (17)

Secondary Outcomes (17)

Study Arms (2)

Safety Cohort (Phase 1b)

Expansion Cohort (Phase 2a)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations