A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty (NCT06070532)
A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIa Clinical Study of Cellcolabs' Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (29 items).
Location: To be decided — Nassau
Age range: 60 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- To be decided — Nassau,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: 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 Adv...
More studies in Frailty
- Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty — St John's,
- Frailty Rehabilitation — Hamilton, Ontario
- High Intensity Interval Training (HIIT) to Reduce Frailty and Enhance Resilience in Older Veterans — Kansas City, Missouri
- Meal Delivery and Exercise — Houston, Texas
- SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery — New York, New York
Explore by condition: All Frailty clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.