A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration

NCT06074783 | Recruiting Phase 1 DMC

• 1 other identifier: 2023-002-BHS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are: To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately) Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of human allogenic BM derived MSCs in musculoskeletal injuries and/or degeneration for all patients either face to face or remotely.

  To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event 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 for all patients either face to face or remotely.

  From baseline to 1 year

Secondary Outcomes (5)

• To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area

  From baseline to 1 year

• Change in Health-related quality of life according to Short-Form 36

  From baseline to 1 year

• Change in Health-related quality of life according to Patient Global Impression of Change

  From baseline to 1 year

• Change in pain assessment

  From baseline to 1 year

• Changes in pain between different treatment subgroups

  From baseline to 1 year

Study Arms (1)

MSC Intervention Group

EXPERIMENTAL

Participants will be enrolled into one of four subgroups listed below Firm connective tissue injury (Cartilage, bone, disc, and meniscus) Firm connective tissue degeneration (Cartilage, bone, disc, and meniscus) Soft connective tissue injury (Ligament, tendons, and muscles) Soft connective tissue degeneration (Ligament, tendons, and muscles) Treatment: Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered. Minimum interval between two local doses is 2 months and systemic doses is 3 months.

Biological: Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)

Interventions

Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte) BIOLOGICAL

50 x 106 allogeneic BM-derived MSCs formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under state of the art way of application that is ultrasound guidance which will ensure precise delivery of the BM derived MSCs at the site of injury or degeneration along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury or degeneration is not feasible.

MSC Intervention Group

Eligibility Criteria

• Age: 18 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 ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.

You may not qualify if:

• Unwilling or unable to perform any of the assessments required by the protocol.
• Have an injury that is expected to selfheal within 14 days without remaining sequel.
• Have an injury for which there is solid scientific evidence that the study compound will have no effect.
• Have an injury that require an orthopaedic surgery that has not been addressed by local/home surgeon.
• Have end stage liver or renal disease.
• 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.
• Hepatitis B virus positive
• Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
• Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.
• Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of \<25%.
• Uncontrolled hypertension (resting systolic blood pressure \>220 mm Hg or diastolic blood pressure of \> 150 mm Hg at screening) .
• Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.
• Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
• Severe acute infection at time of screening and treatment with study drug

Sponsors & Collaborators

• Cellcolabs Clinical LTD.: lead

Study Sites (1)

Live Well

Nassau, The Bahamas, The Bahamas

RECRUITING

MeSH Terms

Interventions

Pharmaceutical Preparations

Central Study Contacts

Rikin Patel, DO

CONTACT

+1 (908) 864 2991

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 4, 2023
• First Posted: October 10, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): October 19, 2027
• Study Completion (Estimated): October 19, 2028
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

TH (1)