Individual Patient Expanded Access IND of Autologous HB-adMSCS for the Treatment of Bilateral Knee Pain.

NO_LONGER_AVAILABLE

Conditions studied: Knee Pain Chronic, Osteo Arthritis Knee

In brief

This is an Individual Patient Expanded Access IND of autologous adipose derived Mesenchymal Stem Cells with the primary goal of treating 1 individual with bilateral knee pain who has exhausted all treatment options, his condition has not improved, and his quality of life is severely affected by the condition. There are no FDA approved, fully restorative treatments for his condition. The subject will receive 2 autologous HB-adMSCs intravenous infusion of 200 million (2 x 10\^8 cells) total cells, and 4 autologous HB-adMSCs intra-articular injections (1 in each knee joint/ intervention).

Key facts

Study ID

NCT04604288

Run by

Hope Biosciences Research Foundation

Last updated by the study team

2025-09-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of bilateral knee pain.
• Hemodynamically stable.

You may not qualify if…

• Immunosuppression as defined by WBC < 3, 000 cells/ml at baseline screening.
• Subjects with pro-coagulant disease processes such as Factor V Leiden deficiency, Factor C and S deficiency, anti-thrombin deficiency, prothrombin mutation, and dysfibrinogenemia.
• Subjects with abnormal vital signs, abnormal liver or kidney function, and hematological abnormalities specifically:
• BP systolic: >160 or <100 mmHg, DBP: >100 SBP or <50mmHg
• Pulse: <60 or >105 bpm
• Respiratory Rate: <9 and >25 breaths per minute
• Temperature: >99.9 degrees Fahrenheit
• O2 saturation: <92%
• Liver enzymes >2x upper limit of normal (ULN)
• Abnormal bilirubin unless due to benign unconjugated hyperbilirubinemia
• eGFR <60 mL/min/ 1.73 m2 by CKD-EPI
• HbA1C >9%
• Hb <10 mg/dL
• Platelet Count <100,000
• Other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation or HB-adMSCs administration.
• Any abnormal, inexplicable laboratory result with no obvious cause defined.
• Participation in other interventional research studies.
• Unwillingness to return for follow-up visits.

Where it is running

• Hope Biosciences Stem Cell Research Foundation — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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