Clinical trial NCT05147675: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for OA
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis
Spinal Arthritis
Keywords: Osteoarthritis
stem cell treatment
Spinal Arthritis
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells delivered intravenously and intraarticularly for the treatment of Osteoarthritis.

Detailed description: Studies have shown that stem cell treatment is safe and efficacious for the treatment of Osteoarthritis (OA). This patient funded trial aims to study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of OA. Patients with OA will receive intravenous infusion and intraarticular injection of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Osteoarthritis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
measure: Efficacy: Single Assessment Numeric Evaluation Score (SANE)
timeFrame: Four year follow-up
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
city: Glyfáda
country: Greece
facility: Athens Beverly Hills Medical Group
state: Athens
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Jin W, Liu H, Cui Y, Mao Q, Fei Z, Xiang C. [CURATIVE EFFECT OF HUMAN UMBILICAL CORD MESENCHYMAL STEM CELLS BY INTRA-ARTICULAR INJECTION FOR DEGENERATIVE KNEE OSTEOARTHRITIS]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2016 Dec 8;30(12):1472-1477. doi: 10.7507/1002-1892.20160305. Chinese.
citation: Khalifeh Soltani S, Forogh B, Ahmadbeigi N, Hadizadeh Kharazi H, Fallahzadeh K, Kashani L, Karami M, Kheyrollah Y, Vasei M. Safety and efficacy of allogenic placental mesenchymal stem cells for treating knee osteoarthritis: a pilot study. Cytotherapy. 2019 Jan;21(1):54-63. doi: 10.1016/j.jcyt.2018.11.003. Epub 2018 Dec 3.
citation: Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, Li S, Xu C, Lu Q, Dai C. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Res Ther. 2019 Oct 21;10(1):308. doi: 10.1186/s13287-019-1406-7.
citation: Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.