Stem Cell Therapy for Osteoarthritis

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InGeneron, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others

Disqualifiers: Inflammatory arthritis, Rheumatoid arthritis, Severe osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, randomized, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressant therapy, chemotherapy, or have received a corticosteroid injection in the treatment site.

Is stem cell therapy for osteoarthritis safe?

Research shows that stem cell therapy for osteoarthritis, specifically using adipose-derived cells, is generally safe. Some patients experienced mild and temporary pain and swelling at the injection site, but no serious side effects were reported. ^{1 2 3 4 5}

How is adipose-derived stem cell injection different from other treatments for osteoarthritis?

Adipose-derived stem cell injection is unique because it uses stem cells from fat tissue to potentially repair and regenerate damaged cartilage in osteoarthritis, unlike traditional treatments that mainly focus on pain relief and inflammation reduction. ^{1 5 6 7 8}

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that injecting adipose-derived regenerative cells (ADRCs) into the knee can help improve symptoms and repair cartilage in people with osteoarthritis. Studies in both humans and animal models have demonstrated positive outcomes, such as reduced progression of the disease and improved joint function. ^{1 5 6 9 10}

Who Is on the Research Team?

Robert Vandermark, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

Adults aged 18-75 with chronic wrist osteoarthritis confirmed by symptoms and radiographs, who can consent to participate. Excluded are pregnant or breastfeeding individuals, recent tobacco users, those with substance abuse history, certain infections (HIV, Hepatitis B/C), allergies to specific anesthetics or contrast agents, participants in other trials, chemotherapy patients, vulnerable populations unable to consent properly (e.g., mentally disabled), and those with inflammatory arthritis conditions or carpal tunnel syndrome.

Inclusion Criteria

I have symptoms like pain or stiffness in my wrist.

My wrist arthritis was confirmed by X-ray.

I can make my own medical decisions or have someone who can.

Exclusion Criteria

I have a history of severe joint or bone conditions, including arthritis or osteoporosis.

I have been diagnosed with carpal tunnel syndrome.

Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of adipose-derived regenerative cells or corticosteroid into the wrist

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adipose-derived stem cell injection
• Corticosteroid injection

Trial Overview The study is testing the safety and effectiveness of a single injection of adipose-derived stem cells (ADRCs) compared to corticosteroid injections for treating chronic wrist osteoarthritis. Participants will be randomly assigned to receive either ADRCs or corticosteroids without knowing which one they get.

How Is the Trial Designed?

Group I: Adipose Derived Regenerative Cell group Experimental Treatment 1 Intervention

Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .

Group II: Corticosteroid group Active Control 1 Intervention

Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.

Adipose-derived stem cell injection is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Adipose-derived stem cell injection for:

• Osteoarthritis of the facet joint
• Chronic lumbar back pain

Approved in European Union as Adipose-derived stem cell injection for:

• Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks

Approved in Canada as Adipose-derived stem cell injection for:

• Orthopedic conditions such as osteoarthritis, joint arthritis, degenerative vertebral disks

Who Is Running the Clinical Trial?

InGeneron, Inc.

Lead Sponsor

Trials

9

Recruited

710+

Sanford Health

Collaborator

Trials

53

Recruited

2,067,000+

Published Research Related to This Trial

In a study involving 11 patients with knee osteoarthritis, treatment with adipose-derived regenerative cells (ADRCs) led to significant improvements in knee function and pain relief, sustained for at least 6 months after injection.

Second-look arthroscopy revealed that ADRC treatment was more effective in repairing low-grade cartilage lesions compared to more severely damaged areas, with no patients experiencing worsening of their condition or requiring knee surgery during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-Look Arthroscopic Findings and Clinical Outcomes after Adipose-Derived Regenerative Cell Injection in Knee Osteoarthritis. Onoi, Y., Hiranaka, T., Hida, Y., et al.[2022]

Intra-articular injection of adipose-derived stromal cells (ASCs) in a rabbit model of osteoarthritis significantly reduced disease progression and promoted healing in cartilage and menisci compared to control groups, indicating their potential efficacy in treating OA.

The ASCs were found to localize in the synovial membrane and medial meniscus, suggesting that their therapeutic effects may be due to a trophic mechanism involving the release of growth factors and cytokines, rather than direct integration into cartilage tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular delivery of adipose derived stromal cells attenuates osteoarthritis progression in an experimental rabbit model. Desando, G., Cavallo, C., Sartoni, F., et al.[2022]

In a study involving two patients with knee osteoarthritis, treatment with adipose-derived regenerative cells (ADRCs) led to significant improvements in pain and knee function over six months, as measured by the Visual Analogue Scale (VAS) and Knee Outcome in Osteoarthritis Score (KOOS).

Second-look arthroscopy revealed that nearly all cartilage defects were covered by regenerated cartilage and some meniscus tears were repaired, indicating that a single injection of ADRCs may effectively promote cartilage and meniscus repair in knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-look arthroscopic findings of cartilage and meniscus repair after injection of adipose-derived regenerative cells in knee osteoarthrits: Report of two cases. Onoi, Y., Hiranaka, T., Nishida, R., et al.[2022]

Intra-articular administration of adipose tissue-derived stem cells (ADSC) significantly improved knee function and pain scores (KOOS) at 6 months, especially in patients with moderate OA (Kellgren-Lawrence grades 2 and 3) compared to those with severe OA (grade 4).

The study found that while KOOS scores improved, changes in cartilage volume after ADSC treatment did not correlate with these clinical improvements, suggesting that the mechanism of action may not solely depend on cartilage volume changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injection of culture-expanded adipose tissue-derived stem cells for knee osteoarthritis: Assessments with clinical symptoms and quantitative measurements of articular cartilage volume. Kuwasawa, A., Okazaki, K., Noda, K., et al.[2023]

Transplantation of dedifferentiated fat (DFAT) cells into osteochondral defects in rats led to significant cartilage repair, with defects showing complete filling by micromass pellets as early as 2 weeks post-treatment.

The DFAT cell-transplanted limbs exhibited significantly better macroscopic and histological scores compared to control limbs, indicating that DFAT cells may be an effective therapeutic strategy for repairing cartilage injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of dedifferentiated fat cell-derived micromass pellets contributed to cartilage repair in the rat osteochondral defect model. Shimizu, M., Matsumoto, T., Kikuta, S., et al.[2018]

The study evaluated the safety of intra-articular injections of adipose-derived stromal cells (ASCs) in 18 patients with severe knee osteoarthritis (OA) and found no serious adverse events, indicating that the treatment is safe.

Patients receiving low-dose ASCs reported significant improvements in pain and function after 6 months, suggesting potential efficacy, although further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Pers, YM., Rackwitz, L., Ferreira, R., et al.[2022]

A review of 2,011 injections of autologous mesenchymal stem cells (AMSCs) for treating arthritis found no specific adverse events, indicating that these injections are completely safe.

The study concluded that AMSCs do not pose an increased risk of complications such as infections or tumor formation compared to traditional arthritis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. Prodromos, C., Rumschlag, T.[2021]

The study involved 22 patients with knee osteoarthritis, and it found that injections of allogeneic human adipose-derived mesenchymal progenitor cells were safe, with only mild to moderate transient adverse events reported.

Patients showed improvements in pain and function over 48 weeks, particularly in the low-dose group, indicating potential benefits of this treatment for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells in patients with symptomatic bilateral knee osteoarthritis: a Phase I pilot study. Lu, L., Dai, C., Du, H., et al.[2021]

Adipose-derived stem cells (ASCs) have shown significant potential in regenerative therapy due to their ability to differentiate into various cell types and modulate immune responses, making them a promising option for treating osteoarthritis (OA).

Current research indicates that ASCs could provide a novel approach to address the pathophysiology of OA, which currently lacks curative treatments, highlighting their potential role in future cell therapies for this common joint disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose derived stem cells for regenerative therapy in osteoarticular diseases. Pers, YM., Jorgensen, C.[2017]

In a study comparing 42 patients receiving adipose-derived stem cells (ASCs) and 38 patients receiving stromal vascular fraction (SVF) for knee osteoarthritis, ASCs led to earlier and greater reductions in pain and symptoms after 3 months.

Both treatments were safe, but ASCs had fewer minor complications related to the fat harvest site and a lower incidence of knee effusion compared to SVF, suggesting ASCs may be a more effective and safer option for treating knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Clinical Outcomes After Intra-articular Injection With Adipose-Derived Cultured Stem Cells or Noncultured Stromal Vascular Fraction for the Treatment of Knee Osteoarthritis. Yokota, N., Hattori, M., Ohtsuru, T., et al.[2020]

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Second-Look Arthroscopic Findings and Clinical Outcomes after Adipose-Derived Regenerative Cell Injection in Knee Osteoarthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intra-articular delivery of adipose derived stromal cells attenuates osteoarthritis progression in an experimental rabbit model. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Second-look arthroscopic findings of cartilage and meniscus repair after injection of adipose-derived regenerative cells in knee osteoarthrits: Report of two cases. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Intra-articular injection of culture-expanded adipose tissue-derived stem cells for knee osteoarthritis: Assessments with clinical symptoms and quantitative measurements of articular cartilage volume. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Transplantation of dedifferentiated fat cell-derived micromass pellets contributed to cartilage repair in the rat osteochondral defect model. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Intra-articular injections of allogeneic human adipose-derived mesenchymal progenitor cells in patients with symptomatic bilateral knee osteoarthritis: a Phase I pilot study. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Adipose derived stem cells for regenerative therapy in osteoarticular diseases. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Comparative Clinical Outcomes After Intra-articular Injection With Adipose-Derived Cultured Stem Cells or Noncultured Stromal Vascular Fraction for the Treatment of Knee Osteoarthritis. [2020]