Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness

NCT06600581 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STEM-META
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief Summary

Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness

Conditions

Muscle Performance; Sarcopenic Obesity

Keywords

Muscle Performance; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Safety and tolerability of the IP will be measured by regular monitoring of study subjects' vital signs, blood and urine testing, symptom assessments, physical examinations and physical function testing to identify changes that may be related to the IP. Monitoring begins before treatment and continues for three months following the completion of treatment.

  Time Frame: Day 0 to Day 28

• Change over time in gait speed

  Muscle strength and function efficacy information from this measure will be used to determine a dosing regimen for a confirmatory expanded study. This will be done using the The European Working Group on Sarcopenia in Older People (EWGSOP2) diagnostic criteria of sarcopenia gait speed.

  Time Frame: Day 0 to Day 171

Secondary Outcomes (3)

• Change over time in grip strength

  Time Frame: Day 0 to Day 171

• Change over time in body composition using DXA

  Time Frame: Day 0 to Day 171

• Change over time in actigraphy parameters as reported by a wearable activity tracker

  Time Frame: Day 0 to Day 171

Study Arms (5)

Group 1

PLACEBO COMPARATOR

Placebo - 2 mL USP injectable saline, twice a week

Other: Placebo

Group 2

EXPERIMENTAL

0.5 mg total protein in 2 mL final volume, twice a week

Biological: IMM01-STEM

Group 3

EXPERIMENTAL

1 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline)

Biological: IMM01-STEM alternating with placebo (saline)

Group 4

EXPERIMENTAL

1 mg total protein in 2 mL final volume twice a week

Biological: IMM01-STEM

Group 5

EXPERIMENTAL

2 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline)

Biological: IMM01-STEM alternating with placebo (saline)

Interventions

IMM01-STEM alternating with placebo (saline) BIOLOGICAL

This intervention consists of IMM01-STEM given once a week and placebo given one a week. IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling.

Group 3; Group 5

IMM01-STEM BIOLOGICAL

IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling. This intervention is given 2mL twice a week.

Group 2; Group 4

Placebo OTHER

Saline. This intervention is given 2mL twice a week.

Also known as: Saline

Group 1

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: male or female
• Age 60 to 80 years of age at the time of signing the informed consent.
• Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
• Disease characteristics: To be eligible, the participant must meet at least one criterion for obesity and at least one criterion for sarcopenia, as defined below:
• Obesity:
• Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for women (World Health Organization)
• Sarcopenia:
• Grip strength women: \< 16 kg, men: \< 27 kg in the dominant hand Gait speed \< 0.8 m/s (men and women)
• Acceptable stages:

You may not qualify if:

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the STEM-META clinical protocol
• In order to understand the nature of this study it is expected that most participants will be able to speak, read, and understand English, or Spanish however, additional translations of the informed consent may be made available after study initiation to include additional languages for participants
• Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator.
• To be eligible for enrollment and for each treatment administration, the vital signs pre-dose, should be in the following ranges. If the vitals are outside of the range, will be reassessed 3 times at 10 minutes resting intervals.
• Heart rate \>50 and \<100 bpm Systolic pressure \>100 and \<170 mmHg Diastolic pressure \>50 and \<100 mmHg Blood oxygenation (by pulse-oximetry) \>95%
• Unmanaged/uncontrolled comorbidities (examples include high blood pressure, hyperglycemia, unstable angina, deep vein thrombosis, hepatic cirrhosis, peptic ulcers, complicated GERD, COPD, asthma etc.) as judged by the investigator.
• Type 1 Diabetes Mellitus, insulin-dependent Type 2 Diabetes mellitus, or hemoglobin A1C level \>7.0%
• Severe obesity, or class III obesity (CDC criteria, BMI \>40)
• Current diagnosis of major psychiatric disorders that may impact participation, as judged by the investigator.
• Study participant has current or past history of invasive malignancy (5 years) excluding non-melanoma skin cancer.
• Inflammatory conditions requiring regular use of oral or parenteral corticosteroids (Raynaud phenomenon, scleroderma, rheumatoid arthritis, LED etc.).
• Cushing's syndrome, Graves disease (hyperthyroidism), or other condition of hormone imbalance caused by genetic or auto-immune disorder. Exceptions include controlled hypothyroidism and polycystic ovarian syndrome.
• Severe cardiovascular disease (including New York Heart Association \[NYHA\] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator)
• Parkinson's disease, multiple sclerosis or other progressive neurological disorders
• Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2)

Sponsors & Collaborators

• Immunis, Inc.: lead

Study Sites (4)

National Institute of Clinical Research (NICR)

Garden Grove, California, 92844, United States

Location

National Institute of Clinical Research (NICR)

Pomona, California, 91768, United States

Location

Johnson Country Clinical Trials (JCCT)

Lenexa, Kansas, 66219, United States

Location

Tekton Research

Wichita, Kansas, 67218, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tom Lane, PhD

  Chief Science Officer at Immunis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The following roles indicated below will not be made aware of the treatment group assignment during the trial: Participants Investigators Outcomes assessor The person responsible for drug dispensing (pharmacist) will be unblinded Sponsor staff or designees may be unblinded to complete ongoing safety oversight and surveillance reporting. A planned unblinding will take place at the interim analysis for dose selection in the next phase and futility.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: STEM-META is a placebo-controlled, randomized, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa). The treatment period and follow up will last 16 weeks, then an interim adaptation will initiate the second phase of the study (IIb). Treatment Groups Group 1 - Placebo - 2 mL USP injectable saline, twice a week Group 2 - 0.5 mg total protein in 2 mL final volume, twice a week Group 3 - 1 mg total protein in 2 mL final volume, once a week, alternating with saline Group 4 - 1 mg total protein in 2 mL final volume twice a week Group 5 - 2 mg total protein in 2 mL final volume, once a week, alternating with saline

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)