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

Conditions

• Chronic Obstructive Lung Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stem cells — BIOLOGICAL
  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.

Study Details

This study is a phase 1b/2a, open-label, non-randomized, observation of 125 adults, with moderate to severe chronic obstructive pulmonary disease, treated with SORT-COPD (SMS cells). The primary objective of this study is to evaluate the preliminary within-participant changes of SORT-COPD (SMS cells), in suspension, delivered to the lung as an aerosolized mist via a vibrating mesh nebulizer, on respiratory health status in participants with moderate to severe chronic obstructive pulmonary disease.

Key Dates

First listed

Oct 13, 2026

Start date

Oct 1, 2026

Status verified

Oct 2026

Primary completion

Oct 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

125 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Cohort (Phase 1b)
  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.
• Experimental: Expansion Cohort (Phase 2a)
  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.

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: Baseline through 12 months ]

Central Contacts

• Chief Clinical Officer
  +1
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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