Safety and Tolerability Study of Mesenchymal Stem Cells, HeXell-2020, in Elderly Subjects With Mild to Moderate Frailty Syndrome

NCT07144072 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HeXell-2020-FS-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome. HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.

Conditions

Frailty in Older Adults

Keywords

HeXell-2020; Mesenchymal Stem Cells (MSC); Frailty Syndrome (FS)

Outcome Measures

Primary Outcomes (3)

• Maximum Feasible Dose (MFD) determination

  MFD is determined on the occurrence of Dose Limiting Toxicities (DLTs) after IV administration in elderly subjects with mild to moderate FS. DLT is defined as any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as ≥ Grade 3 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0), where applicable, is assessed as unrelated to disease progression, concurrent illness, or concomitant medications and occurring within 14 days after completion of the last study treatment .

  Within 14 days after completion of the last study treatment (day 28 for 3 doses treatment and day 70 for 6 doses treatment ) .

• Incidence of Treatment-Emergent Adverse Events (TEAEs).

  TEAE are defined as adverse events with onset date on or after the first treatment. TEAEs will be summarized by treatment group, System Organ Class, and preferred term. The following TEAE summaries will be provided: 1. Overall (i.e., regardless of severity or relationship to treatment) 2. Adverse events by severity 3. Related adverse events by severity 4. Adverse events leading to treatment discontinuation by severity 5. Adverse events leading to death by severity

  Within the first year after cell transplantation.

• Incidence of withdrawals due to AEs

  An adverse event (AE) is will be classified by system organ class (SOC) and preferred term (PT) according to the most recent version of MedDAR dictionary.

  Within the first year after cell transplantation.

Secondary Outcomes (7)

• Mean change from baseline in exercise performance as measured by change in the six-minute walk test (6MWT) total distance.

  Day 0 (baseline), Week 6, 12, 24, 36, 52

• Mean change from baseline in hand grip strength as measured by change in maximum force using hand dynamometer.

  Day 0 (baseline), Week 6, 12, 24, 36, 52

• Mean change from baseline in physical activity as measured by change in the Short Physical Performance Battery (SPPB) assessment total score.

  Day 0 (baseline), Week 6, 12, 24, 36, 52

• Mean change from baseline in Clinical Frailty Scale (CFS) score.

  Day 0 (baseline), Week 6, 12, 24, 36, 52

• Mean change from baseline in quality of life as measured by change in the Falls Efficacy Scale- International (FES-I) questionnaire score.

  Day 0 (baseline), Week 6, 12, 24, 36, 52

Study Arms (1)

Cell Drug:HeXell-2020

EXPERIMENTAL

Two cohort. Cohort 1: HeXell-2020 will be administered by intravenous once every two weeks, and a total of 3 doses. Cohort 2: HeXell-2020 will be administered by intravenous once every two weeks, and a total of 6 doses.

Drug: HeXell-2020

Interventions

HeXell-2020 DRUG

Cohort 1: 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 3 doses Cohort 2 : 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 6 doses

Cell Drug:HeXell-2020

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
• Subjects aged ≥ 60 through ≤ 85 years old.
• Subjects with clinical diagnosis of mild to moderate Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to 6.
• Subject will not start any new treatment for this condition during the study.
• Subjects with body weight between 40 to 90 kg.
• Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

You may not qualify if:

• Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
• Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
• Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.
• Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.
• Subjects who have a significant comorbid medical condition(s) including, but not limited to:
• Severe kidney disease requiring hemodialysis or peritoneal dialysis;
• Advanced liver disease such as severe liver cirrhosis;
• Severe congestive heart failure (NYHA class 3 and 4);
• Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification)
• Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma or in situ carcinomas.
• Subjects using chronic immunosuppressant therapy, including corticosteroids (\> 5 mg/day of prednisone, or equivalent), or TNF-alpha antagonists.
• Subjects on chronic immunosuppressive transplant therapy.
• Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening.
• Subjects who have received any other stem cell therapy within 12 months prior to screening.
• Subjects with known allergy or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin).

Sponsors & Collaborators

• Hexun Biosciences Co., LTD.: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simon Huang, Dr.

CONTACT

+88633175088; simon.huang@hexunbio.com

Wannhsin Chen, Dr.

CONTACT

+88633175088; whsin.chen@hexunbio.com

Study Design

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

Model Details: Single arm, 2 dose cohorts with dose-defining escalation

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share