Aging FrailtyPhase 1/2NCT06063590
A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients
A Phase 1/2 study testing StromaForte in people with Aging Frailty, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Aging Frailty
- What is being tested?
- StromaForte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 22 Jan 2024to 28 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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)
- Have any clinically important abnormal screening laboratory values, including, but not limited to: i. Haemoglobin <10.0 g/dL, ii. White blood cell <2,500/ul, or platelet count <100,000/ul iii. Liver dysfunction evidenced by enzymes (AST and ALT) > 3 times the upper limit of normal (ULN)
- Coagulopathy with international normalized ratio (INR) >1.3 not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors)
- Uncontrolled hypertension (resting systolic blood pressure >180 mm Hg or diastolic blood pressure of > 110 mm Hg at Screening)
- Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months
- Have congestive heart failure defined by New York Heart Association (NYHA) Class III or IV, or an ejection fraction of <25
- Have a coronary artery bypass surgery, angioplasty, or peripheral vascular disease revascularization or a myocardial infarction within previous 3 months
- Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels <60 mmHg
- Have a partial ileal gastric bypass, or other significant intestinal malabsorption
- Have advanced liver or renal disease
- Have cognitive or language barriers that prohibit obtaining informed consent or any study elements
- (or participated within the previous 30 days of consent) in an investigational Currently hospitalized or living in an assisted living facility or a long-term care facility
- Currently participating therapeutic or device trial
- Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte in Patients With Aging Frailty
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.
Read the detailed description
Frailty is theoretically defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. In the absence of a gold standard, frailty has been operationally defined by Fried et al. as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss.
One major factor proposed to contribute to frailty and related epigenetic dysregulation is stem cell loss. In order to treat this multifactorial dysregulation, stem cell therapy is an interesting strategy, and MSCs are a particularly tempting candidate. MSCs are an immune-privileged somatic progenitor cell type that is multipotent, self-renewing, and relatively simple to harvest (bone marrow harvest), isolate, and grow. MSCs are proven to regulate the body's immune response in many diseases and exert anti-inflammatory effects.
Following their discovery over 50 years ago, mesenchymal stromal cells (MSCs) have become one of the most studied cellular therapeutic products by both academia and industry due to their regenerative potential and immunomodulatory properties. The promise of MSCs as a therapeutic modality has been demonstrated in a number of preclinical studies as well as in clinical setting. Stromaforte cells which will be used in this study is developed within CELLCOLABS AB which is a parent company to Cellcolabs Clinical SPV Limited and were generated following the same protocol established over the last 20 years by scientists CELLCOLABS AB at the Karolinska Institute in Sweden.
Currently completed in vivo studies on rats, rabbits and mice models showed that MSCs could attenuate sarcopenia via increasing skeletal muscle weight and myofiber cross-sectional area. The physical performance including muscle strength as well as endurance were significantly enhanced. In addition, MSCs have capability to activate resident skeletal muscle stem cells, which lead to myogenesis and differentiation of muscle tissues. The positive results provide novel insights into sarcopenia intervention, suggesting a potential role for MSC therapy in aging frailty. This study which has been designed to evaluate the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte in frail patients before further clinical development.
- Conditions
- Aging Frailty
- Being tested
- StromaForte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StromaForteBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: StromaForte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days post-infusion
Secondary outcomes (4)
Change in TNF-alpha
Change in tumor necrosis factor α TNF-α from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Measured: From baseline to 6 months
Change in C Reactive Protein (CRP)
Change in C Reactive Protein (CRP) from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Measured: From baseline to 6 months
Change in Interleukin-6 (IL-6)
Change in Interleukin-6 (IL-6) from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Measured: From baseline to 6 months
Change in Complete Blood Count (CBC) in peripheral blood with differential
Change in Complete Blood Count (CBC) in peripheral blood with differential from baseline to 6 months (baseline to 28-, 84-, and 168-days post-infusion.)
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start22 Jan 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellcolabs Clinical SPV Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PDC-CRO
- Responsible party
- Sponsor
- Investigators
- Fahti Yousef, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063590
- Sponsor's protocol ID
- 00-Frailty Study-2022
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Arm Phase I/IIa Study to Evaluate the Safety of Human Allogenic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte in Patients With Aging Frailty
- ClinicalTrials.gov ID
- NCT06063590
- Acronym / sponsor ID
- 00-Frailty Study-2022
- Conditions
- Aging Frailty
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cellcolabs Clinical SPV LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PDC-CRO
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frailty is theoretically defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. In the absence of a gold standard, frailty has been operationally defined by Fried et al. as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss.
One major factor proposed to contribute to frailty and related epigenetic dysregulation is stem cell loss. In order to treat this multifactorial dysregulation, stem cell therapy is an interesting strategy, and MSCs are a particularly tempting candidate. MSCs are an immune-privileged somatic progenitor cell type that is multipotent, self-renewing, and relatively simple to harvest (bone marrow harvest), isolate, and grow. MSCs are proven to regulate the body's immune response in many diseases and exert anti-inflammatory effects.
Following their discovery over 50 years ago, mesenchymal stromal cells (MSCs) have become one of the most studied cellular therapeutic products by both academia and industry due to their regenerative potential and immunomodulatory properties. The promise of MSCs as a therapeutic modality has been demonstrated in a number of preclinical studies as well as in clinical setting. Stromaforte cells which will be used in this study is developed within CELLCOLABS AB which is a parent company to Cellcolabs Clinical SPV Limited and were generated following the same protocol established over the last 20 years by scientists CELLCOLABS AB at the Karolinska Institute in Sweden.
Currently completed in vivo studies on rats, rabbits and mice models showed that MSCs could attenuate sarcopenia via increasing skeletal muscle weight and myofiber cross-sectional area. The physical performance including muscle strength as well as endurance were significantly enhanced. In addition, MSCs have capability to activate resident skeletal muscle stem cells, which lead to myogenesis and differentiation of muscle tissues. The positive results provide novel insights into sarcopenia intervention, suggesting a potential role for MSC therapy in aging frailty. This study which has been designed to evaluate the safety of intravenous human allogenic bone marrow-derived mesenchymal stromal cell product StromaForte in frail patients before further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MSC arm | Experimental | Biological: StromaForteThe 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 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StromaForte100 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 | Biological | MSC arm |
Primary outcome
Safety
Time frame: 28 days post-infusion
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
4 secondary outcomes
Change in TNF-alpha
Time frame: From baseline to 6 months
Change in C Reactive Protein (CRP)
Time frame: From baseline to 6 months
Change in Interleukin-6 (IL-6)
Time frame: From baseline to 6 months
Change in Complete Blood Count (CBC) in peripheral blood with differential
Time frame: From baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahti Yousef, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing StromaForte in people with Aging Frailty, run by Cellcolabs Clinical SPV Limited at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.