Orthopedics

Cell Therapy provides many options for the patient looking for alternatives to orthopedic surgical procedures or seeking treatments to accelerate healing after surgical repair or injury of tendons and ligaments. Dr. Habrecht is the most experienced and knowledgeable Orthopedic Surgeon in the region in Regenerative Medicine and Cell Therapy providing exceptional care for her patients.

Conditions: 

  • Osteoarthritis
  • Rotator Cuff Tears
  • Tendon/Ligament Tear
  • Cartilage Injury
  • Meniscus Tears
  • Tendonitis
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Osteoarthritis 

Osteoarthritis is the degeneration or breakdown of cartilage on the surface of bone in the joint. This cartilage serves as a shock absorber. Osteoarthritis can be caused by trauma, increased impact activity, overuse, genetic predisposition, obesity and is more common in women and the elderly. When the cartilage degenerates, this can cause pain, stiffness, swelling with increased activity, bone spurs and grinding or cracking with joint motion.

Scientific Articles

Concentrated adipose tissue infusion for the treatment of knee osteoarthritis: clinical and histological observations
 2019 Jan;43(1):15-23. doi: 10.1007/s00264-018-4192-4. Epub 2018 Oct 11
 
 

Abstract

Purpose

Osteoarthritis (OA) is characterized by articular cartilage degeneration and subchondral bone sclerosis. OA can benefit of non-surgical treatments with collagenase-isolated stromal vascular fraction (SVF) or cultured-expanded mesenchymal stem cells (ASCs). To avoid high manipulation of the lipoaspirate needed to obtain ASCs and SVF, we investigated whether articular infusions of autologous concentrated adipose tissue are an effective treatment for knee OA patients.

Methods

The knee of 20 OA patients was intra-articularly injected with autologous concentrated adipose tissue, obtained after centrifugation of lipoaspirate. Patients’ articular functionality and pain were evaluated by VAS and WOMAC scores at three, six and 18 months from infusion. The osteogenic and chondrogenic ability of ASCs contained in the injected adipose tissue was studied in in vitro primary osteoblast and chondrocyte cell cultures, also plated on 3D-bone scaffold. Knee articular biopsies of patients previously treated with adipose tissue were analyzed. Immunohistochemistry (IHC) and scanning electron microscopy (SEM) were performed to detect cell differentiation and tissue regeneration.

Results

The treatment resulted safe, and all patients reported an improvement in terms of pain reduction and increase of function. According to the osteogenic or chondrogenic stimulation, ASCs expressed alkaline phosphatase or aggrecan, respectively. The presence of a layer of newly formed tissue was visualized by IHC staining and SEM. The biopsy of previously treated knee joints showed new tissue formation, starting from the bone side of the osteochondral lesion.

Conclusion

Overall our data indicate that adipose tissue infusion stimulates tissue regeneration and might be considered a safe treatment for knee OA.

https://www.ncbi.nlm.nih.gov/pubmed/30311059

Autologous and micro-fragmented adipose tissue for the treatment of diffuse degenerative knee osteoarthritis
2017 Dec; 4: 33.   |   Published online 2017 Oct 3. doi:  10.1186/s40634-017-0108-2
PMCID: PMC5626678   |   PMID: 28975547

A. Russo,1 V. Condello,1 V. Madonna,1 M. Guerriero,2 and C. Zorzi1  Author information ► Article notes ► Copyright and License information ► Disclaimer

 

Abstract

Background

Chondral lesions of the knee represent a challenge for the orthopaedic surgeon. Several treatments have been proposed with variable success rate. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have shown promising results. The adipose tissue is a good source of these naturally occurring regenerative cells, due to its abundance and easy access. In addition, it can be used to provide cushioning and filling of structural defects. The 1-year safety and outcome of a single intra-articular injection of autologous and micro-fragmented adipose tissue in 30 patients affected by diffuse degenerative chondral lesions was evaluated.

Methods

Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. The safety of the procedure was evaluated by recording type and incidence of any adverse event. The clinical outcomes were determined using the KOOS, IKDC-subjective, Tegner Lysholm Knee, and VAS pain scales taken pre-operatively and at 12 months follow-up. A level of at least 10 points of improvement in the scores has been selected as cut-off representing a clinically significant difference.

Results

No relevant complications nor clinical worsening were recorded. A total median improvement of 20 points has been observed in IKDC-subjective and total KOOS, and a higher percentage of success was found in VAS pain and Tegner Lysholm Knee, where the total median improvement was 24 and 31 points, respectively.

Conclusion

The results of this study show the safety and feasibility of using autologous and micro-fragmented adipose tissue in patients affected by diffuse degenerative chondral lesions. The technique is safe, minimally invasive, simple, one-step, with low percentage of complications, and compliant with the regulatory panorama.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5626678/

The Effect of Intra-articular Injection of Autologous Microfragmented Fat Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis
2017 Oct 13;8(10). pii: E270. doi: 10.3390/genes8100270.
Hudetz D1,2,3Borić I4,5,6Rod E7Jeleč Ž8Radić A9Vrdoljak T10,11Skelin A12,13Lauc G14,15Trbojević-Akmačić I16Plečko M17Polašek O18,19Primorac D20,21,22,23,24,25,26.

Abstract

Osteoarthritis (OA) is one of the leading musculoskeletal disorders in the adult population. It is associated with cartilage damage triggered by the deterioration of the extracellular matrix tissue. The present study explores the effect of intra-articular injection of autologous microfragmented adipose tissue to host chondrocytes and cartilage proteoglycans in patients with knee OA. A prospective, non-randomized, interventional, single-center, open-label clinical trial was conducted from January 2016 to April 2017. A total of 17 patients were enrolled in the study, and 32 knees with osteoarthritis were assessed. Surgical intervention (lipoaspiration) followed by tissue processing and intra-articular injection of the final microfragmented adipose tissue product into the affected knee(s) was performed in all patients. Patients were assessed for visual analogue scale (VAS), delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) and immunoglobulin G (IgG) glycans at the baseline, three, six and 12 months after the treatment. Magnetic resonance sequence in dGEMRIC due to infiltration of the anionic, negatively charged contrast gadopentetate dimeglumine (Gd-DTPA2-) into the cartilage indicated that the contents of cartilage glycosaminoglycans significantly increased in specific areas of the treated knee joint. In addition, dGEMRIC consequently reflected subsequent changes in the mechanical axis of the lower extremities. The results of our study indicate that the use of autologous and microfragmented adipose tissue in patients with knee OA (measured by dGEMRIC MRI) increased glycosaminoglycan (GAG) content in hyaline cartilage, which is in line with observed VAS and clinical results.

https://www.ncbi.nlm.nih.gov/pubmed/29027984

Current perspectives in mesenchymal stem cell therapies for osteoarthritis
 2014;2014:194318. doi: 10.1155/2014/194318. Epub 2014 Dec 8.

Kristjánsson B1Honsawek S2Author information

1 DEPARTMENT OF BIOCHEMISTRY, FACULTY OF MEDICINE, CHULALONGKORN UNIVERSITY, KING CHULALONGKORN MEMORIAL HOSPITAL, THAI RED CROSS SOCIETY, 1873 RAMA IV ROAD, PATHUMWAN, BANGKOK 10330, THAILAND.
2 DEPARTMENT OF BIOCHEMISTRY, FACULTY OF MEDICINE, CHULALONGKORN UNIVERSITY, KING CHULALONGKORN MEMORIAL HOSPITAL, THAI RED CROSS SOCIETY, 1873 RAMA IV ROAD, PATHUMWAN, BANGKOK 10330, THAILAND ; DEPARTMENT OF ORTHOPAEDICS, FACULTY OF MEDICINE, CHULALONGKORN UNIVERSITY, KING CHULALONGKORN MEMORIAL HOSPITAL, THAI RED CROSS SOCIETY, 1873 RAMA IV ROAD, PATHUMWAN, BANGKOK 10330, THAILAND.

Abstract

Osteoarthritis (OA) is a degenerative joint disease most commonly occurring in the ageing population. It is a slow progressive condition resulting in the destruction of hyaline cartilage followed by pain and reduced activity. Conventional treatments have little effects on the progression of the condition often leaving surgery as the last option. In the last 10 years tissue engineering utilising mesenchymal stem cells has been emerging as an alternative method for treating OA. Mesenchymal stem cells (MSCs) are multipotent progenitor cells found in various tissues, most commonly bone marrow and adipose tissue. MSCs are capable of differentiating into osteocytes, adipocytes, and chondrocytes. Autologous MSCs can be easily harvested and applied in treatment, but allogenic cells can also be employed. The early uses of MSCs focused on the implantations of cell rich matrixes during open surgeries, resulting in the formation of hyaline-like durable cartilage. More recently, the focus has completely shifted towards direct intra-articular injections where a great number of cells are suspended and injected into affected joints. In this review the history and early uses of MSCs in cartilage regeneration are reviewed and different approaches in current trends are explained and evaluated.

Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee
2014 Dec;24(8):1505-11. doi: 10.1007/s00590-013-1393-9. Epub 2014 Jan 8.
 

Abstract

Purpose

As a treatment method of degenerative arthritis of knee, this study evaluated the clinical efficacy of the intra-articular injection of autologous bone marrow aspirates concentrate (BMAC) with adipose tissue.

Materials and Methods

Between April 2011 and May 2012, 41 patients (75 knees) who were diagnosed as a degenerative knee arthritis and underwent the BMAC injection with adipose tissue were included in this study. Mean age was 60.7 years old (ranged 53-80). Kellgren-Lawrence grade was used for assessing radiologic degree of osteoarthritis; there were each 12, 24, 33, and 6 cases of grade I, II, III, and IV. At preoperative and postoperative 3, 6, and 12 months, pain score using visual analogue scale (VAS) and functional scales were used for evaluation.

Results

After the procedure, mean VAS score was decreased from 7.0 preoperatively to 4.1, 3.5, and 3.3 postoperatively 3, 6, and 12 months. And functional scores were also improved; International Knee Documentation Committee score (from 37.7 preoperatively to 59.3, 66.3, 69.3 postoperatively), SF-36 health score (from 31.5 to 43.5, 45.6, 47.7), knee and osteoarthritis outcome score (from 43.1 to 64.9, 68.5, 70.6), Lysholm Knee Questionnaire (from 37.3 to 65.4, 68.6, 71.0) were all increased after the procedure. When classified according to K-L grade, the improvement of VAS score in grade IV group was 8.2 preoperatively to 5.5, 5.3, and 5.7 postoperatively, which was significantly poorer than those of grade I-III groups. In the knee functional scales, similar pattern was checked.

Conclusions

BMAC injection significantly improved both knee pain and functions in the patients with degenerative arthritis of knee. Also, the injection would be more effective in early to moderate phases.

https://www.ncbi.nlm.nih.gov/pubmed/24398701

Mesenchymal stem cell injections improve symptoms of knee osteoarthritis
2013 Apr;29(4):748-55. doi: 10.1016/j.arthro.2012.11.017. Epub 2013 Jan 29.
 

Abstract

Purpose

The purpose of this study was to evaluate the clinical and imaging results of patients who received intra-articular injections of autologous mesenchymal stem cells for the treatment of knee osteoarthritis.

Methods

The study group comprised 18 patients (6 men and 12 women), among whom the mean age was 54.6 years (range, 41 to 69 years). In each patient the adipose synovium was harvested from the inner side of the infrapatellar fat pad by skin incision extension at the arthroscopic lateral portal site after the patient underwent arthroscopic debridement. After stem cells were isolated, a mean of 1.18 × 10(6) stem cells (range, 0.3 × 10(6) to 2.7 × 10(6) stem cells) were prepared with approximately 3.0 mL of platelet-rich plasma (with a mean of 1.28 × 10(6) platelets per microliter) and injected into the selected knees of patients. Clinical outcome was evaluated with the Western Ontario and McMaster Universities Osteoarthritis Index, the Lysholm score, and the visual analog scale (VAS) for grading knee pain. We also compared magnetic resonance imaging (MRI) data collected both preoperatively and at the final follow-up.

Results

Western Ontario and McMaster Universities Osteoarthritis Index scores decreased significantly (P < .001) from 49.9 points preoperatively to 30.3 points at the final follow-up (mean follow-up, 24.3 months; range, 24 to 26 months). Lysholm scores also improved significantly (P < .001) by the last follow-up visit, increasing from a mean preoperative value of 40.1 points to 73.4 points by the end of the study. Likewise, changes in VAS scores throughout the follow-up period were also significant (P = .005); the mean VAS score decreased from 4.8 preoperatively to 2.0 at the last follow-up visit. Radiography showed that, at the final follow-up point, the whole-organ MRI score had significantly improved from 60.0 points to 48.3 points (P < .001). Particularly notable was the change in cartilage whole-organ MRI score, which improved from 28.3 points to 21.7 points (P < .001). Further analysis showed that improvements in clinical and MRI results were positively related to the number of stem cells injected.

Conclusion

The results of our study are encouraging and show that intra-articular injection of infrapatellar fat pad-derived mesenchymal stem cells is effective for reducing pain and improving knee function in patients being treated for knee osteoarthritis.

https://www.ncbi.nlm.nih.gov/pubmed/23375182

Cartilage Injury

The cartilage on the surface of the bone can be injured due to trauma or damaged from osteoarthritis. This creates a localized defect in the cartilage which can be painful, and cause the joint to catch with motion and swell.

Scientific Articles

One-Step Cartilage Repair with Bone Marrow Aspirate Concentrated Cells and Collagen Matrix in Full–Thickness Knee Cartilage Lesions: Results at 2–Year Follow-up

n 2011, Gobbi et al. published results of 15 patiens who underwent surgery for focal cartilage defects in the knee which included implanting bone marrow ­derived stem cells in a cartilage matrix to fill the defect. MRI at 2 years showed complete filling of the defect in 12/15 and there was significant improvement in pain and function.


2011 Jul;2(3):286-99. doi: 10.1177/1947603510392023.
 

Abstract

Objective

The purpose of our study was to determine the effectiveness of cartilage repair utilizing 1-step surgery with bone marrowaspirate concentrate (BMAC) and a collagen I/III matrix (Chondro-Gide, Geistlich, Wolhusen, Switzerland).

Materials and Methods 

We prospectively followed up for 2 years 15 patients (mean age, 48 years) who were operated for grade IV cartilage lesions of the knee. Six of the patients had multiple chondral lesions; the average size of the lesions was 9.2 cm(2). All patients underwent a mini-arthrotomy and concomitant transplantation with BMAC covered with the collagen matrix. Coexisting pathologies were treated before or during the same surgery. X-rays and MRI were collected preoperatively and at 1 and 2 years’ follow-up. Visual analog scale (VAS), International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Lysholm, Marx, SF-36 (physical/mental), and Tegner scores were collected preoperatively and at 6, 12, and 24 months’ follow-up. Four patients gave their consent for second-look arthroscopy and 3 of them for a concomitant biopsy.

Results

Patients showed significant improvement in all scores at final follow-up (P < 0.005). Patients presenting single lesions and patients with small lesions showed higher improvement. MRI showed coverage of the lesion with hyaline-like tissue in all patients in accordance with clinical results. Hyaline-like histological findings were also reported for all the specimens analyzed. No adverse reactions or postoperative complications were noted.

Conclusion

This study showed that 1-step surgery with BMAC and collagen I/III matrix could be a viable technique in the treatment of grade IV knee chondral lesions.

https://www.ncbi.nlm.nih.gov/pubmed/?term=One%C2%ADStep+cartilage+repair+with+bone+marrow+aspirate+concentrated+cells+and+collagen+matrix+in+full%C2%AD+thickness+knee+cartilage+lesions%3A+results+at+2%C2%AD+year+follow%C

Rotator Cuff Tear 

The shoulder is a ball and socket joint. The rotator cuff consists of 4 tendons that originate as muscles on the scapula. These tendons attach to the humerus or ball of the shoulder. The rotator cuff is responsible for arm rotation and overhead lifting. Tears tend to be gradual in onset and occur more commonly in those over age 50. The shoulder may be painful with activity and is typically worse at night. Weakness may occur, particularly with lifting away from the body and overhead activity.

Scientific Articles

Does an Injection of Adipose-Derived Mesenchymal Stem Cells Loaded in Fibrin Glue Influence Rotator Cuff Repair Outcomes?

Yong Sang Kim,* MD, Chang Hun Sung,* MD, Sung Hoon Chung,* MD, Sang Joon Kwak,y MD, and Yong Gon Koh,* z MD Investigation performed at the Center for Stem Cell & Arthritis Research, Department of Orthopaedic Surgery, Yonsei Sarang Hospital, Seoul, Republic of Korea

Background

The mesenchymal stem cell (MSC)–based tissue engineering approach has been developed to improve the treatment of rotator cuff tears.

Hypothesis/Purpose

The purpose was to determine the effect of an injection of adipose-derived MSCs loaded in fibrin glue during arthroscopic rotator cuff repair on clinical outcomes and to evaluate its effect on structural integrity using magnetic resonance imaging (MRI). The hypothesis was that the application of adipose-derived MSCs would improve outcomes after the surgical repair of a rotator cuff tear.

Study Design

Cohort study; Level of evidence, 3.

Methods

Among 182 patients treated with arthroscopic surgery for a rotator cuff tear, 35 patients treated with arthroscopic rotator cuff repair alone (conventional group) were matched with 35 patients who underwent arthroscopic rotator cuff repair with an injection of adipose-derived MSCs loaded in fibrin glue (injection group) based on sex, age, and lesion size. Outcomes were assessed with respect to the visual analog scale (VAS) for pain, range of motion (ROM) (including forward flexion, external rotation at the side, and internal rotation at the back), and functional measures of the Constant score and University of California, Los Angeles (UCLA) shoulder rating scale. Repaired tendon structural integrity was assessed by using MRI at a minimum of 12 months after surgery, and the mean clinical follow-up was 28.8 6 4.2 months in the conventional group and 28.3 6 3.8 months in the injection group.

Results

The mean VAS score at rest and during motion improved significantly in both groups after surgery. However, there were no significant differences between the groups at the final follow-up (P = .256 and .776, respectively). Compared with preoperative measurements, forward flexion and external rotation at the side significantly improved at the final follow-up in both groups (all P.05). However, no significant improvements in internal rotation at the back were observed in either group (P = .625 and .834 for the conventional and injection groups, respectively). There were also no significant differences between the groups at the final followup for any of the 3 ROM positions (all P . .05). The mean Constant score and UCLA score improved significantly in both groups after surgery, but there were no significant differences between the groups at the final follow-up (P = .634 and .302, respectively). MRI indicated a retear rate of 28.5% in the conventional group and 14.3% in the injection group (P .001).

Conclusion

This study revealed that an injection of adipose-derived MSCs loaded in fibrin glue during rotator cuff repair could significantly improve structural outcomes in terms of the retear rate. There were, however, no clinical differences in the 28-month period of follow-up. Although still in the early stages of application, MSC augmentation of surgical rotator cuff repair appears useful for providing an adequate biological environment around the repair site.

http://journals.sagepub.com/doi/pdf/10.1177/0363546517702863

Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study

2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.

 

Abstract

Purpose

The purpose of this study was to evaluate the efficiency of biologic augmentation of rotator cuff repair with iliac crest bone marrow-derived mesenchymal stem cells (MSCs). The prevalence of healing and prevention of re-tears were correlated with the number of MSCs received at the tendon-to-bone interface.

Methods

Forty-five patients in the study group received concentrated bone marrow-derived MSCs as an adjunct to single-row rotator cuff repair at the time of arthroscopy. The average number of MSCs returned to the patient was 51,000 ± 25,000. Outcomes of patients receiving MSCs during their repair were compared to those of a matched control group of 45 patients who did not receive MSCs. All patients underwent imaging studies of the shoulder with iterative ultrasound performed every month from the first postoperative month to the 24th month. The rotator cuff healing or re-tear was confirmed with MRI postoperatively at three and six months, one and two years and at the most recent follow up MRI (minimum ten-year follow-up).

Results

Bone marrow-derived MSC injection as an adjunctive therapy during rotator cuff repair enhanced the healing rate and improved the quality of the repaired surface as determined by ultrasound and MRI. Forty-five (100 %) of the 45 repairs with MSC augmentation had healed by six months, versus 30 (67 %) of the 45 repairs without MSC treatment by six months. Bone marrow concentrate (BMC) injection also prevented further ruptures during the next ten years. At the most recent follow-up of ten years, intact rotator cuffs were found in 39 (87 %) of the 45 patients in the MSC-treated group, but just 20 (44 %) of the 45 patients in the control group. The number of transplanted MSCs was determined to be the most relevant to the outcome in the study group, since patients with a loss of tendon integrity at any time up to the ten-year follow-up milestone received fewer MSCs as compared with those who had maintained a successful repair during the same interval.

Conclusion

This study showed that significant improvement in healing outcomes could be achieved by the use of BMC containing MSC as an adjunct therapy in standard of care rotator cuff repair. Furthermore, our study showed a substantial improvement in the level of tendon integrity present at the ten-year milestone between the MSC-treated group and the control patients. These results support the use of bone marrow-derived MSC augmentation in rotator cuff repair, especially due to the enhanced rate of healing and the reduced number of re-tears observed over time in the MSC-treated patients.

https://www.ncbi.nlm.nih.gov/pubmed/24913770

Conventional rotator cuff repair complemented by the aid of mononuclear autologous stem cells

2012 Feb;20(2):373-7. doi: 10.1007/s00167-011-1607-9. Epub 2011 Jul 20.

Conventional rotator cuff repair complemented by the aid of mononuclear autologous stem cells.

 

Abstract

Purpose

To investigate the behavior of rotator cuff tears treated with  conventional repair  technique with the  aid of  autologous bone marrow mononuclear cells (BMMC).

Methods

Fourteen consecutive patients (9 women, 5 men, mean age of 59.2 years) with complete rotator cuff tears (mean preoperative UCLA score of 12 ± 3.0) were fixed by transosseous stitches through mini-open incision, with subsequent injection of BMMC into the tendon borders, obtained from the iliac crest just prior to surgery. Magnetic resonance images (MRI) were acquired before and after surgery and evaluated by two musculoskeletal radiologists regarding new postoperative findings of patients treated with BMMC.

Results

After a minimum 12-month follow-up period, the UCLA score increased from 12 ± 3.0 to 31 ± 3.2. Clinical findings remained unaltered in the following year in all but one patient (13/14). MRI analysis after a 12-month follow-up period demonstrated tendon integrity in all cases (14/14), presence of low-signal intensity areas along the supraspinatus tendon and distal muscle belly in 8 cases (8/14), and high-intensity blooming small round artifact at the bursal and tendon topography in 11 cases (11/14). Six patients (6/14) showed formation of a high-signal intensity zone at the critical zone. Clinical findings remained unaltered in the following year in all but one patient, who relapsed into loss of strength and pain, being considered a bad result.

Conclusion

Implantation of BMMC in rotator cuff sutures appears to be a safe and promising alternative to other biological approaches currently used to enhance tissue quality in affected tendons.

https://www.ncbi.nlm.nih.gov/pubmed/?term=Conventional+rotator+cuff+repair+complemented+by+the+aid+of+mononuclear+autologous+stem+cells

MeniscusTear 

The meniscus is a “C”-shaped cartilage that acts as a shock absorber for the cartilage on the surface of the bone. Tears of the meniscus usually occur as a result of a twisting injury, but may occur due to repetitive trauma, arthritis and increased age. Symptoms are often intermittent depending on activity and can include pain, swelling, popping and catching and tend to be worse with squatting, kneeling and impact activity.

Scientific Articles

Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study
 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.

Abstract

BACKGROUND:

There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee. Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation. In a randomized, double-blind, controlled study, the safety of the intra-articular injection of human mesenchymal stem cells into the knee, the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy, and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated.

METHODS:

A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy. A single superolateral knee injection was given within seven to ten days after the meniscectomy. Patients were randomized to one of three treatment groups: Group A, in which patients received an injection of 50 × 10⁶ allogeneic mesenchymal stem cells; Group B, 150 × 10⁶ allogeneic mesenchymal stem cells; and the control group, a sodium hyaluronate (hyaluronic acid/hyaluronan) vehicle control. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI).

RESULTS:

No ectopic tissue formation or clinically important safety issues were identified. There was significantly increased meniscal volume (defined a priori as a 15% threshold) determined by quantitative MRI in 24% of patients in Group A and 6% in Group B at twelve months post meniscectomy (p = 0.022). No patients in the control group met the 15% threshold for increased meniscal volume. Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments.

CONCLUSIONS:

There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00225095.

 

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