A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

NCT06063590 | Completed Phase 1

• 1 other identifier: 00-Frailty Study-2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I/IIa study in frail patients is designed to assess the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte by reporting the number of adverse events assessed by Common Terminology Criteria. 12 male and female patients aged 60 to 85 years will be enrolled.

Conditions

Aging Frailty

Outcome Measures

Primary Outcomes (1)

• Safety

  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 along with others Adverse Events and Serious Adverse events

  28 days post-infusion

Secondary Outcomes (4)

• Change in TNF-alpha

  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 (6)

• Change in the 6-minute walk test

  From baseline to 6 months

• Change in hand grip strength

  From baseline to 6 months

• Change in EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS)

  From baseline to 6 months

Study Arms (1)

MSC arm

EXPERIMENTAL

The patients will be receiving allogeneic bone marrow (BM)-derived Mesenchymal Stromal Cell (MSC) formulated in infusion solution (sodium chloride supplemented with human serum albumin) in a low intravenous infusion of 100 millions MSCs within approximately 30 min

Biological: StromaForte

Interventions

StromaForte BIOLOGICAL

100 millions 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 in approximately 30 min

MSC arm

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• 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/ml

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 discretion
• Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
• Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-α 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 SPV Limited: lead
• PDC-CRO: collaborator

Study Sites (1)

Burjeel Medical City

Abu Dhabi, United Arab Emirates

Location

Study Officials

• Fahti Yousef, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The patients will be assigned into one group receiving allogeneic bone marrow (BM)- derived Mesenchymal Stromal Cell (MSC) formulated in infusion solution (sodium chloride supplemented with human serum albumin Pre-screening visit will be conducted within 7 days of the screening visit then eligible patient will participate in the Study for approximately 6 months and will have a total of 5 on-site visits, including a screening visit, a treatment administration visit, and 3 follow-up visits.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 2, 2023
• Study Start: January 22, 2024
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)