A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty

NCT06070532 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: MROS/220622/INDTP
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty. The main questions it aims to answer are: To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) Observe the change in inflammatory markers from baseline to 6 months (baseline to 28, 84, and 168 days post-infusion.) Participants will receive 100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product Stromaforte

  To assess the safety and tolerability after 28 days of injection by reporting the number of adverse events assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment

  Post 28 day infusion

Secondary Outcomes (4)

• Change in tumor necrosis factor α (TNF-α)

  From baseline to 6 months

• Change in C Reactive Protein (CRP)

  From baseline to 6 months

• Change in Interleukin-6 (IL-6)

  From baseline to 6 months

• Change in Complete Blood Count (CBC) in peripheral blood with differential

  From baseline to 6 months

Other Outcomes (7)

• Change in the 6-minute walk test (6-MWT)

  From baseline to 6 months

• Change in hand grip strength (dynamometry)

  From baseline to 6 months

• Change in EQ-5D-3L

  From baseline to 6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

12 female or male patients suffering from aging frailty

Biological: Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)

Interventions

Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte) BIOLOGICAL

100 x 106 allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion 100 million cells in approximately 30 min

Intervention group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent and comply with all procedures required by the protocol
• Aged \> 60 and \< 85 years at the time of signing the informed consent form
• Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 "mildly frail" or 6 "moderately frail"
• Have a 6-minute walk distance of \> 200m and \< 400 m
• Have a serum TNF-alpha level \>2.5 pg/m

You may not qualify if:

• Unwilling or unable to perform any of the assessments required by the protocol
• Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia
• Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
• Have poorly controlled blood glucose levels (HbA1c \>8.0%).
• Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.
• Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion
• Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus).
• Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of \< 5 mg daily is allowed)
• Hepatitis B virus positive
• Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
• Have a resting blood oxygen saturation of \<93% (measured by pulse oximetry).
• Known or suspected alcohol or drug abuse within three years preceding Screening
• Have a known hypersensitivity to dimethyl sulfoxide (DMSO).
• An organ transplant recipient (other than transplantation for corneal).
• Actively listed (or expected future listing) for transplant of any organ (other than corneal transplant).

Sponsors & Collaborators

• Cellcolabs Clinical LTD.: lead

Study Sites (1)

To be decided

Nassau, The Bahamas

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

TH (1)