A Study to Evaluate the Safety of Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product StromaForte for the Treatment of Knee Osteoarthritis

NCT06084988 | Completed Phase 1 DMC

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

Brief Summary

This open-label, single-arm, phase I/II study in mild-to-moderate stage knee osteoarthritis patients is designed to assess the safety and tolerability of intraarticular human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. 12 male and/or female patients aged over 18 years will be enrolled. The main questions it aims to answer are: To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed 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). Eligible patients will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasoundguided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• To assess safety and tolerability within 24 hours,4 days , 28, 84 and 168 days of MSC injection

  To assess the safety and tolerability of StromaForte within 24 hours, 4 days ,28 days, 84, and 168 post injection during site visits and post injection by telephone calls. Safety and tolerability will be assessed 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

  From baseline to 6 months

Secondary Outcomes (10)

• Change from baseline in subjective pain assessment according to the VAS questionnaire 84, 168 days after treatment

  From baseline to 6 months

• Change from baseline in knee-joint specific function assessed by the Knee Injury and osteoarthritis outcome score (KOOS) at 84- and 168-days post-injection

  From baseline to 6 months

• Change from baseline in arthritis pain scores using the Lequesne index assessment at 84- and 168-days post treatment

  From baseline to 6 months

• Change in Health-related quality of life according to Short-Form 12 at 168 days post-injection

  From baseline to 6 months

• Change in TNF-alpha in synovial fluid

  From baseline to 6 months

Other Outcomes (1)

• Change from baseline of cell composition of blood and synovial fluids

  From baseline to 6 months

Study Arms (1)

MSC Intervention Group

EXPERIMENTAL

Participants will receive one dose (50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution (sodium chloride supplemented with human serum albumin) to be given via ultrasound-guided intra-articular injection of human allogeneic bone marrow-derived mesenchymal stromal cell product StromaForte. All patients will be observed for at least 2 hours post-injection at the study site. Both active monitoring and spontaneous reporting will be used.

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

Interventions

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

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 via ultrasound-guided intra-articular injection

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
• Diagnosed with knee OA according to American College and Rheumatology criteria and showing a stage of a mild to moderate arthritis.
• Kellgren-Lawrence radiological classification scale II and III at screening
• Visual analogue scale (VAS) joint pain ≥ 2.5 at screening
• Have tried but failed conservative management including physical therapy, bracing and medications for a minimum of three months.
• No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
• No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
• Adequate liver and renal functions with non-malignant blood profile.
• Body Mass Index between 20 and 30 kg/m2
• Negative for (HIV, HTLV1\&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
• Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
• Fluid \> 1 cm within the lateral recess of the suprapatellar pouch at the level of the superior pole of the patella with the knee extended.

You may not qualify if:

• Unwilling or unable to perform any of the assessments required by the protocol
• Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
• Patients with varus or valgus malalignment \>5 degrees as measured by 4-foot standing antero-posterior radiographs
• Patients with a history of a previous subtotal medial or lateral meniscectomy
• Patients with a history of septic arthritis in the affected joint
• Patients with a history of a prior intra-articular knee fracture
• Severe bleeding diathesis
• Active infection
• Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g., patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator
• Patients with neoplasia
• Patients with a known history of inflammatory or rheumatic diseases such as rheumatoid arthritis

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

  Cellcolabs Clinical SPV Limited

  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

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 16, 2023
• Study Start: November 7, 2023
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

AE (1)